EU → North America 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 was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa598
Class IIb1

Most frequent device types declared: 52141, 85761, 85763, 93012, D8200.

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

Devices declared under this manufacturer

Showing 12 of 599 declared devices.

Catalogue references include 2-132, 52141, 85763, 85784S, E1817 S, E3916.

European nomenclature codes declared: L170299, Q021101, L1713, L1711, Q021199, L0205.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED599
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN599
Found in the U.S. device database330
Share55.1 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBAUSCH & LOMB, INC.

North American profile: Canada only. Bausch & Lomb GmbH holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

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

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