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Address: Depagaten 2, Anderstorp 33421, Sweden
www.hartmann.se |
Phone: +46-(371)-58-74-00
Annual Revenues: < USD 1 Million
Employee Count: ~30
Quality: ISO 9002, CE Certified
Products: Drainage Bag, Nasal Aspirator, Baby Nasal Aspirator, Suction Aspirator, Antibacterial Cleaner Solution, Incontinence Mattress, ...
Hartmann ScandiCare AB specializes in offering wound care and incontinence products. Our wound care products include bandages, and compression & support bandages. We offer a wide range of hydro-active
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Address: Boseind 15, Rm Boxtel B-5281, Netherlands
www.organonteknika.com |
Phone: +31-(411)-654486
Annual Revenues: USD 100-500 Million
Employee Count: ~2250
Quality: ISO 9001, CE Certified
Products: Coagulation Analyzers (FDA Code:
GKP), POC Coagulation Analyzers (PT and INR), Prostatic Acid Phosphatase, Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Automated Coagulation Analyzer (FDA Code:
GKP), Fertility Monitors, Pregnancy Test Kits, ...
Organon Teknika B.V. manufactures HIV diagnostic products, including NucliSens® HIV-1 viral load and nucliSens HIV-1 RNA detection assays. Our product line includes nucleic acid sequence-based HIV
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Address: Via Giovanni XXIII, 174, Carpi, MO 41012, Italy
Phone: +39-(59)-633-611
Annual Revenues: USD 10-25 Million
Employee Count: ~80
Quality: ISO 9002 Certified
Products: Electrodes and Other Components, Gold Cup Electrodes, Barium Accessories, Tubing Clamps, Tubing Clamps, Luer Fittings, Medical Tubing Clamps, Plastic Tubing Clamp, ...
Comef deals with individual components and connectors used in the manufacture of sets for dialysis, IV therapy, infusion, nutrition, enteral & parenteral feeding bags, cardio-surgery tubing sets & ass
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Address: Else-Kroener-Strasse 1, Bad Homburg v.d.H. 61352, Germany
www.fresenius.se |
Send Inquiry |
Phone: +49-(6172)-608
Annual Revenues: USD 1-5 Million
Employee Count: ~7350
Quality: ISO 9000, CE Certified
Products: Volumetric Infusion Pumps, Intravenous Catheters, Infusion Pumps, Ambulatory Pumps, Femoral Catheter (FDA Code:
LFK), PCA Pumps, Infusion Pump, Dual-Channel Volumetric Infusion Pump, ...
Fresenius is a global health care company with products and services for dialysis, hospitals & the medical care of patients at home. We deal with hemodialysis, acute dialysis, peritoneal dialysis, dia
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FDA Code / Regulation: FKY / 876.5820 A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.