Profile: Heraeus Holding Gmbh specializes in medical products. Our medical products include pacemaker components, hypotubes, X-ray components, surgical instrumentation, guide wires, pins, steerable instrument, coatings, core wires, strips, rods, and micro components. Our surgical instruments are used in arthroscopic surgery, endoscopy, endourology, fracture management, and bone fixation applications. We also provide biopsy devices, catheters, cutting forceps and drill guides.

The company has revenues of USD 100-500 Million, has ~9220 employees and is ISO 9001, ISO 9002 certified.

FDA Registration Number: 9617472
US Agent: Marilyn Barry / Thermo Fisher Scientific
Phone: +1-(828)-658-4400  E-Mail:

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• Anaerobic Glove Box (FDA Code: JTM / 866.2120) An anaerobic chamber is a device intended for medical purposes to maintain an anaerobic (oxygen free) environment. It is used to isolate and cultivate anaerobic microorganisms.

• Assisted Reproduction Accessory (FDA Code: MQG / 884.6120) Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:

• Automated Slide Stainer (FDA Code: KPA / 864.3800) An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

• Automated Tissue Processor (FDA Code: IEO / 864.3875) An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

• Automated Tissue Stainer (FDA Code: KEY / 864.3800)

• Automatic Rotary Microtome (FDA Code: IDO / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Bench Mounted Hopper for X-Ray Film

• Biological Sterilization Process Indicator (FDA Code: FRC / 880.2800) A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

• Blood Storage Freezer (FDA Code: KSE / 864.9700) A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.

• Blue Rare Earth X-Ray Film

• Cardiac Insulation Pad

• Ceiling Mounted Surgical Light (FDA Code: FSY / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Cell-Freezing Apparatus and Reagents (FDA Code: KSP / 864.9225) Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.

• Central Gas System Alarm

• Chloride Ion Specific Electrode (FDA Code: CGZ / 862.1170) A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

• Communication Equipment

• Contract Manufacturing

• Cryostat Microtome (FDA Code: IDP / 864.3010)

• Cytocentrifuge (FDA Code: IFB / 864.3300) A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.

• Dental X-Ray Film

• Diagnostic Blood Bank Centrifuge (FDA Code: KSO / 864.9275) A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160) A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Electronic Components Tape

• Endovascular Stent

• Examination (Light) Lamp

• External Pacemaker Electrode

• Germicidal Ultraviolet Lamp

• Glucose Hexokinase Test (FDA Code: CFR / 862.1345) A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Green Sensitive Rare Earth X-Ray Film

• Immersion Type Slide Stainer (FDA Code: KIO / 864.3800)

• Incandescent Sun Lamp

• Incubator/ Water Bath (FDA Code: JTQ / 866.2540) A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.

• Ion-Exchange Resin (FDA Code: KEA / 862.2230) A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.

• Labeled Medical Laboratory Equipment (FDA Code: 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.

• Laboratory Freezers (FDA Code: JRM / 862.2050)

• Medical Device, Sterilant (FDA Code: MED / 880.6885) A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

• Medical Metal

• Medical Ultraviolet Water Purifiers (FDA Code: KMG / 880.6710) A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.

• Microsection Sealing Device (FDA Code: KIM / 864.3400) A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.

• Multi Analyte Control (FDA Code: JJY / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Non-Heated Nebulizer

• Orthopedic Prosthesis Implantation Instrument

• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800)

• Platelet Storage Environmental Chamber (FDA Code: KSH / 864.9575) An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.

• Potassium Ion Specific Electrode (FDA Code: CEM / 862.1600) A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

• Radioactive Iridium Wire Source (FDA Code: IWA / 892.5730) A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

• Radiographic X-Ray Film

• Radiotherapy Accessories