EU → US Device Access

Bausch & Lomb GmbH

DE-MF-000009142 · Germany · Eppelheim

Bausch & Lomb GmbH is registered in the European database on medical devices as a manufacturer, with 599 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa598
Class IIb1

Most frequent device types declared: 52141, 85763, 93012, PPT109, E7920.

Among these devices, 151 are declared sterile, 444 reusable, 1 active.

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 entryBausch & Lomb Incorporated (DE) · FDA 3029990829
Devices in EUDAMED599
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.

Notified body certificates

CertificateStatusExpiry
HZ 2520883-1supplemented2028-04-26
HZ 1333770-1issued2028-04-26

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