Labeled Medical Laboratory Equipment Suppliers
Limit companies to: Worldwide USA
Medesy S.R.L. | Address: Industrial Area, Via La Mola, 9, Maniago, PN 33085, Italy
www.medesy.it | Send Inquiry | Phone: +39-(427)-72786
FDA Registration: 9680244 Annual Revenues: USD 1-5 Million Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Trays (FDA Code: LRP), Scalpel Handle (FDA Code: GDZ), Surgical Trays (FDA Code: LRP), Rigid Laryngoscope (FDA Code: CCW), Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Medesy S.R.L. offers dental equipment. We offer products for tooth extraction, surgery, laboratory, orthodontics, and implantalogy. The surgery products are bone files, bone rongeurs, gingivectomy kni more...
www.medesy.it | Send Inquiry | Phone: +39-(427)-72786
FDA Registration: 9680244 Annual Revenues: USD 1-5 Million Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Trays (FDA Code: LRP), Scalpel Handle (FDA Code: GDZ), Surgical Trays (FDA Code: LRP), Rigid Laryngoscope (FDA Code: CCW), Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Medesy S.R.L. offers dental equipment. We offer products for tooth extraction, surgery, laboratory, orthodontics, and implantalogy. The surgery products are bone files, bone rongeurs, gingivectomy kni more...
Narang Medical Limited | Address: Narang Tower, 46 Community Centre, Naraina Ph-I, New Delhi, Delhi 110028, India 
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Medical Thermometers, Stethoscopes, Umbilical Cord Clamps, Vacuum Extractors, Autoclaves, Dry Heat Sterilizers (FDA Code: KMH), ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Medical Thermometers, Stethoscopes, Umbilical Cord Clamps, Vacuum Extractors, Autoclaves, Dry Heat Sterilizers (FDA Code: KMH), ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Berthold Technologies GmbH & Co KG | Address: Calmbacher Str. 22, Bad Wildbad 75323, Germany 
www.bertholdtech.com | Send Inquiry | Phone: +49-(7081)-177-216
Annual Revenues: < USD 1 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: microplate reader, Reconditioned Radiation Counters, Radiation Monitoring Devices, Radiation Monitoring Accessories, Radiation Monitoring, Pulse Rate Monitors, ...
Berthold Technologies GmbH & Co KG offers high performance standard products, optimal solutions for specific customer applications and OEM instruments for biosciences and medicine. Our product list co more...
www.bertholdtech.com | Send Inquiry | Phone: +49-(7081)-177-216
Annual Revenues: < USD 1 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: microplate reader, Reconditioned Radiation Counters, Radiation Monitoring Devices, Radiation Monitoring Accessories, Radiation Monitoring, Pulse Rate Monitors, ...
Berthold Technologies GmbH & Co KG offers high performance standard products, optimal solutions for specific customer applications and OEM instruments for biosciences and medicine. Our product list co more...
W.O.M. World Of Medicine, Gmbh | Address: Salzufer 8, Berlin 10587, Germany
www.world-of-medicine.com | Send Inquiry | Phone: +49-(30)-3 99 81-500
FDA Registration: 8043980
Products: Arthroscopes (FDA Code: HRX), Gas Calibrated Flowmeter (FDA Code: BXY), Gas Pressure Calibrator (FDA Code: BXX), Withdrawal/Infusion Pump (FDA Code: DQI), Labeled Medical Laboratory Equipment (FDA Code: LXG), AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
W.O.M. World Of Medicine, Gmbh is a provider of medical devices used for minimally invasive surgery. We offer the full range of MIS® device technology. Our products include insufflators, pump syst more...
www.world-of-medicine.com | Send Inquiry | Phone: +49-(30)-3 99 81-500
FDA Registration: 8043980
Products: Arthroscopes (FDA Code: HRX), Gas Calibrated Flowmeter (FDA Code: BXY), Gas Pressure Calibrator (FDA Code: BXX), Withdrawal/Infusion Pump (FDA Code: DQI), Labeled Medical Laboratory Equipment (FDA Code: LXG), AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
W.O.M. World Of Medicine, Gmbh is a provider of medical devices used for minimally invasive surgery. We offer the full range of MIS® device technology. Our products include insufflators, pump syst more...
Medium-Tech Gmbh | Address: Gustav-krone Str. 3, Berlin D-14167, Germany
www.medium-tech.de | Send Inquiry | Phone: +49-(030)-845 88 54
Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Labeled Medical Laboratory Equipment (FDA Code: LXG), General Medical Device, Ultrasonic Laparoscopy Imaging System, ...
Medium-Tech Gmbh offers medical devices. We are specialized in the area of aesthetic-corrective medicine pertaining to skin. We also manufacture individually customized PMU products on a small-scale b more...
www.medium-tech.de | Send Inquiry | Phone: +49-(030)-845 88 54
Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Labeled Medical Laboratory Equipment (FDA Code: LXG), General Medical Device, Ultrasonic Laparoscopy Imaging System, ...
Medium-Tech Gmbh offers medical devices. We are specialized in the area of aesthetic-corrective medicine pertaining to skin. We also manufacture individually customized PMU products on a small-scale b more...
Stratec Biomedical Systems AG | Address: Gewerbestrasse 37, Birkenfeld D-75217, Germany
www.stratec-biomedical.de | Send Inquiry | Phone: +49-(7082)-7916-0
FDA Registration: 8043379
Products: Laboratory Equipment, Hematology Analyzers, Hemoglobin Analyzers, Blood, Hematology Analyzers, Automated Hematology Analyzers, Microplate Immunoassay System, ...
Stratec Biomedical Systems AG designs, develops and produces fully automated systems in clinical diagnostics and biotechnology. Our platerunner is a multifunctional analyser system comprising auto-int more...
www.stratec-biomedical.de | Send Inquiry | Phone: +49-(7082)-7916-0
FDA Registration: 8043379
Products: Laboratory Equipment, Hematology Analyzers, Hemoglobin Analyzers, Blood, Hematology Analyzers, Automated Hematology Analyzers, Microplate Immunoassay System, ...
Stratec Biomedical Systems AG designs, develops and produces fully automated systems in clinical diagnostics and biotechnology. Our platerunner is a multifunctional analyser system comprising auto-int more...
MedLas Consult | Address: Auf Der Schleide 18, Bonn 53225, Germany
www.medlas.de | Send Inquiry | Phone: +49-(228)-695-520
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Consulting Services, Video Camera Adapters, High Resolution Microscope Video Cameras, Surgical Microscope Video Camera Adapters, Management Consulting, Onsite Consulting Service, ENT Computer Software, ...
MedLas Consult offers consultancy services in relation to medical technologies, pharmaceuticals and laser technologies. Our products are scientific, industrial and medical laser devices, optical & med more...
www.medlas.de | Send Inquiry | Phone: +49-(228)-695-520
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Consulting Services, Video Camera Adapters, High Resolution Microscope Video Cameras, Surgical Microscope Video Camera Adapters, Management Consulting, Onsite Consulting Service, ENT Computer Software, ...
MedLas Consult offers consultancy services in relation to medical technologies, pharmaceuticals and laser technologies. Our products are scientific, industrial and medical laser devices, optical & med more...
Laborgerateborse Gmbh | Address: Bruck Str 58, Burladingen 72393, Germany
www.labexchange.com | Send Inquiry | Phone: +49-(7475)-9514-0
Annual Revenues: USD 5-10 Million Employee Count: ~10
Products: Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Laborgerateborse Gmbh specializes in laboratory and analysis equipment. We serve laboratories, analytical institutes, clinic laboratories, laboratory technicians, physicians, as well as equipment manu more...
www.labexchange.com | Send Inquiry | Phone: +49-(7475)-9514-0
Annual Revenues: USD 5-10 Million Employee Count: ~10
Products: Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Laborgerateborse Gmbh specializes in laboratory and analysis equipment. We serve laboratories, analytical institutes, clinic laboratories, laboratory technicians, physicians, as well as equipment manu more...
Labotect Labor-Technik Gottingen GmbH | Address: Willi-Eichler-Str. 25, Goettingen D-37079, Germany
www.labotect.com | Send Inquiry | Phone: +49-(551)-50501-0
FDA Registration: 9617654 Year Established: 1971 Employee Count: ~30 Quality: ISO 9002, CE Certified
Products: Incubators, Laboratory Refrigerators - Glass Door, Laboratory Refrigerator & Freezer Combinations, Laboratory Refrigerator - Stainless Steel Doors, Compact Laboratory Refrigerator and Freezer, General Laboratory Refrigerators and Freezer Combinations, ...
Labotect Labor-Technik Gottingen develops, produces and distributes a wide range of products for use in assisted reproduction, medical surgery & life-science laboratories. Our products include punctur more...
www.labotect.com | Send Inquiry | Phone: +49-(551)-50501-0
FDA Registration: 9617654 Year Established: 1971 Employee Count: ~30 Quality: ISO 9002, CE Certified
Products: Incubators, Laboratory Refrigerators - Glass Door, Laboratory Refrigerator & Freezer Combinations, Laboratory Refrigerator - Stainless Steel Doors, Compact Laboratory Refrigerator and Freezer, General Laboratory Refrigerators and Freezer Combinations, ...
Labotect Labor-Technik Gottingen develops, produces and distributes a wide range of products for use in assisted reproduction, medical surgery & life-science laboratories. Our products include punctur more...
Siladent-Technik Gmbh | Address: Im Klei 26, Goslar 38644, Germany
www.siladent.com | Send Inquiry | Phone: +44-(5321)-5321-3779-0
Employee Count: ~20
Products: Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Siladent-Technik Gmbh manufactures and distributes dental laboratory equipment and materials. We provide auxiliary gypsum materials, model system and dental gypsum; type 1, 2, 3, 4 and 5. The dental g more...
www.siladent.com | Send Inquiry | Phone: +44-(5321)-5321-3779-0
Employee Count: ~20
Products: Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Siladent-Technik Gmbh manufactures and distributes dental laboratory equipment and materials. We provide auxiliary gypsum materials, model system and dental gypsum; type 1, 2, 3, 4 and 5. The dental g more...
Bohlender GmbH | Address: Waltersberg 8, Grunsfeld 97947, Germany
www.bola.de | Send Inquiry | Phone: +49-(9346)-92-86-0
Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Thermoplastic Tubing, Suction Connecting Tubing Products, Gas Filtering Tubes, Plastic Tubing Clamp, Plastic Tubing, Connecting Tubing, ...
Bohlender GmbH specializes in lab ware. Our product categories are stirring & mixing, tubing, films, tiles, filtration, screw joints for HPLC, vessels & distillation equipment and pumps. The Bola cult more...
www.bola.de | Send Inquiry | Phone: +49-(9346)-92-86-0
Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Thermoplastic Tubing, Suction Connecting Tubing Products, Gas Filtering Tubes, Plastic Tubing Clamp, Plastic Tubing, Connecting Tubing, ...
Bohlender GmbH specializes in lab ware. Our product categories are stirring & mixing, tubing, films, tiles, filtration, screw joints for HPLC, vessels & distillation equipment and pumps. The Bola cult more...
Heraeus Holding Gmbh | Address: Heraeusstr. 12-14, Hanau 63450, Germany
www.heraeus.com | Send Inquiry | Phone: +49-(6181)-350
FDA Registration: 9617472 Annual Revenues: USD 100-500 Million Employee Count: ~9220 Quality: ISO 9001, ISO 9002 Certified
Products: Oxygen Masks (FDA Code: BYG), X-Ray Film, Rotary Microtomes (FDA Code: IDO), Automatic Rotary Microtome (FDA Code: IDO), Automated Slide Stainer (FDA Code: KPA), Automated Tissue Processor (FDA Code: IEO), ...
Heraeus Holding Gmbh specializes in medical products. Our medical products include pacemaker components, hypotubes, X-ray components, surgical instrumentation, guide wires, pins, steerable instrument, more...
www.heraeus.com | Send Inquiry | Phone: +49-(6181)-350
FDA Registration: 9617472 Annual Revenues: USD 100-500 Million Employee Count: ~9220 Quality: ISO 9001, ISO 9002 Certified
Products: Oxygen Masks (FDA Code: BYG), X-Ray Film, Rotary Microtomes (FDA Code: IDO), Automatic Rotary Microtome (FDA Code: IDO), Automated Slide Stainer (FDA Code: KPA), Automated Tissue Processor (FDA Code: IEO), ...
Heraeus Holding Gmbh specializes in medical products. Our medical products include pacemaker components, hypotubes, X-ray components, surgical instrumentation, guide wires, pins, steerable instrument, more...
Fritsch GmbH | Address: Industriestrasse 8, Idar-Oberstein D-55743, Germany
www.fritsch.de | Send Inquiry | Phone: +49-(6784)-70-0
Year Established: 1920 Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Laboratory Equipment, Milling Instruments, Particle Sizing Instruments, Laboratory Equipment Devices, Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Fritsch GmbH manufactures application orientated laboratory instruments. All our instruments bear CE mark and are manufactured according to the quality standard ISO 9001:2000 .We supply sample prepara more...
www.fritsch.de | Send Inquiry | Phone: +49-(6784)-70-0
Year Established: 1920 Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Laboratory Equipment, Milling Instruments, Particle Sizing Instruments, Laboratory Equipment Devices, Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Fritsch GmbH manufactures application orientated laboratory instruments. All our instruments bear CE mark and are manufactured according to the quality standard ISO 9001:2000 .We supply sample prepara more...
Paul Marienfeld GmbH & Co. KG | Address: Am Wöllerspfad 4, Lauda-Königshofen 97922, Germany
www.superior.de | Send Inquiry | Phone: +49-(9343)-6272-0
FDA Registration: 8010388 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001:2000, CE Certified
Products: Blood Lancets, Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, Sterile Non-Barrier Pipette Tips, Blood Gas Capillary Tubes, ...
Paul Marienfeld GmbH & Co. KG is a manufacturer of a comprehensive range of laboratory glassware. We also distribute products for the general laboratory. Our disposable blood lancets are made of stain more...
www.superior.de | Send Inquiry | Phone: +49-(9343)-6272-0
FDA Registration: 8010388 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001:2000, CE Certified
Products: Blood Lancets, Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, Sterile Non-Barrier Pipette Tips, Blood Gas Capillary Tubes, ...
Paul Marienfeld GmbH & Co. KG is a manufacturer of a comprehensive range of laboratory glassware. We also distribute products for the general laboratory. Our disposable blood lancets are made of stain more...
Roche Diagnostics Gmbh | Address: Sandhoferstrasse 116, Mannheim D-68298, Germany
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Urinalysis System (FDA Code: KQO), Nephelometer (FDA Code: JZW), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products more...
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Urinalysis System (FDA Code: KQO), Nephelometer (FDA Code: JZW), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products more...
Glaswarenfabrik Karl Hecht GmbH & Co KG | Address: Stettenerstr 22-24, Nordheim V D Rhoen 97647, Germany
www.hecht-assistent.com | Send Inquiry | Phone: +49-(9779)-8-08-0
Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Test Tubes, Multi Channel Pipettes, Rimmed Glass Test Tubes, Plastic Test Tube, Giant Test Tubes, Pyrex Test Tubes, ...
Glaswarenfabrik GmbH & Co. KG offers precision instruments and apparatus for physicians & laboratories. Our product range includes urine specimen jars, thermometers, glass jars for cotton, urinometers more...
www.hecht-assistent.com | Send Inquiry | Phone: +49-(9779)-8-08-0
Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Test Tubes, Multi Channel Pipettes, Rimmed Glass Test Tubes, Plastic Test Tube, Giant Test Tubes, Pyrex Test Tubes, ...
Glaswarenfabrik GmbH & Co. KG offers precision instruments and apparatus for physicians & laboratories. Our product range includes urine specimen jars, thermometers, glass jars for cotton, urinometers more...
Sarstedt AG & Co. | Address: Rommelsdorfer Straße, Postfach 1220, Numbrecht 51582, Germany
www.sarstedt.com | Send Inquiry | Phone: +49-(2293)-305-0
FDA Registration: 2242368 Year Established: 1961 Annual Revenues: USD 25-50 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Blood Lancets, Incubators, Capillary Blood Collection Tubes (FDA Code: GIO), Diagnostic Aids, Blood Collect Tubes, Carts, ...
Sarstedt AG & Co. manufactures & distributes equipment and consumables in the field of medicine & research. The S-Monovette® for PFA 100 contains a buffered citrate preparation that is required fo more...
www.sarstedt.com | Send Inquiry | Phone: +49-(2293)-305-0
FDA Registration: 2242368 Year Established: 1961 Annual Revenues: USD 25-50 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Blood Lancets, Incubators, Capillary Blood Collection Tubes (FDA Code: GIO), Diagnostic Aids, Blood Collect Tubes, Carts, ...
Sarstedt AG & Co. manufactures & distributes equipment and consumables in the field of medicine & research. The S-Monovette® for PFA 100 contains a buffered citrate preparation that is required fo more...
Pvt Probenverteiltechnik Gmbh | Address: Maybachstrasse 30, Waiblingen 71332, Germany
www.pvt.de | Send Inquiry | Phone: +49-(7151)-95922-30
Products: Laboratory Equipment, Laboratory Automation Systems, Scanners, Centrifuge Aids, Centrifuges, Automated Laboratory Systems, ...
Pvt Probenverteiltechnik Gmbh is specializes in the manufacture of medical laboratory equipments. Our products include automated centrifuges, camera system for quality assessment QSI™, Decapping more...
www.pvt.de | Send Inquiry | Phone: +49-(7151)-95922-30
Products: Laboratory Equipment, Laboratory Automation Systems, Scanners, Centrifuge Aids, Centrifuges, Automated Laboratory Systems, ...
Pvt Probenverteiltechnik Gmbh is specializes in the manufacture of medical laboratory equipments. Our products include automated centrifuges, camera system for quality assessment QSI™, Decapping more...
Poulten & Graf | Address: Am Bildacker 5-7, Wertheim 97877, Germany
www.graf-fortuna.de | Send Inquiry | Phone: +49-(9342)-92290
Employee Count: ~70
Products: Disposable Syringes, Glass Syringes, Reusable, Pipettes and Liquid Handling, Handheld Dispensers, Burette, Dropping Bottle, Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Poulten & Graf is a manufacturer of high-quality manual and automatic dosing devices, volumetric glassware and medical glass syringes. We are specialized in liquid handling, volumetric glassware, syri more...
www.graf-fortuna.de | Send Inquiry | Phone: +49-(9342)-92290
Employee Count: ~70
Products: Disposable Syringes, Glass Syringes, Reusable, Pipettes and Liquid Handling, Handheld Dispensers, Burette, Dropping Bottle, Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
Poulten & Graf is a manufacturer of high-quality manual and automatic dosing devices, volumetric glassware and medical glass syringes. We are specialized in liquid handling, volumetric glassware, syri more...
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FDA Code / Regulation: LXG / 862.2050
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
