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S.A. GERMITEC

France·FR-MF-000002427

Last updated June 8, 2026

What S.A. GERMITEC makes

S.A. GERMITEC manufactures automated surgical utensil washer/disinfectors, including the CHRONOS model, designed for high-volume medical instrument reprocessing in healthcare settings.

The company’s products fall under EU Class IIb medical devices and are registered in the EUDAMED database. The manufacturer is based in France.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does S.A. GERMITEC manufacture?

S.A. GERMITEC specializes in automated surgical utensil washer/disinfectors, such as the CHRONOS model. These devices are engineered for high-volume reprocessing of medical instruments in clinical environments, ensuring compliance with rigorous hygiene standards for surgical tools.

Where is S.A. GERMITEC based, and what does this mean for its regulatory oversight?

S.A. GERMITEC is headquartered in France, which places its devices under the European Union’s medical device regulations. Since its products fall under EU Class IIb classification, they must meet stringent safety, performance, and risk management requirements before being placed on the market.

Which regulatory registries list S.A. GERMITEC’s devices?

S.A. GERMITEC’s devices are registered in the EUDAMED database, which is the European Union’s centralised system for tracking medical device information. This registry ensures transparency and traceability of devices authorised for use within the EU market.

How are S.A. GERMITEC’s devices classified under EU regulations?

S.A. GERMITEC’s products, including the CHRONOS washer/disinfector, are classified as EU Class IIb medical devices. This classification is based on their intended use in reprocessing critical surgical instruments, where higher risks (e.g., infection control) necessitate more rigorous evaluation and conformity assessment procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
France
Address
19, Rue Vauban, BORDEAUX, France
Website
germitec.com
LinkedIn
—
Facebook
—
Phone
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PRRC Contact
Pascale LAGRANGE
EUDAMED SRN
FR-MF-000002427
FDA FEI Number
—
DUNS Number
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Catalogue (1)

DeviceModel / ReferenceRegistriesClassStatus
Chronos AS1-V2
EUDAMED
Class IIbActive

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