EU → US Device Access

Honeywell Healthcare Solutions GmbH

DE-MF-000004924 · Germany · Wismar

Honeywell Healthcare Solutions GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa9
Class IIb1

Most frequent device types declared: Pulse Oximetry Monitor.

Among these devices, 1 are declared active, 1 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryHoneywell Healthcare Solutions GmbH (formerly EnviteC) (DE) · FDA 9617268
Devices in EUDAMED10
Country of registrationGermany
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Germany

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