Waldemar Link GmbH & Co. KG
DE-MF-000005215 · Germany · Hamburg
Waldemar Link GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 2 068 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 1 847 |
|---|---|
| Class IIb | 221 |
Most frequent device types declared: Acetabular cup, cemented, UHMWPE, CoCrNiMoFe, without snap-fit, concen, Acetabular resurfacing cup, corundum-blasted, uncemented, titanium, re, Articulating surface, UHMWPE, fixed bearing PS, Femoral component, cemented, CoCrMo, UHMWPE, incl. centralizers, Hip Stem, cemented, CoCrMo, XL neck, 126° CCD.
Among these devices, 2 068 are declared sterile, 2 068 implantable.
Catalogue references include 127-626/17, 15-8431/21, 177-555/26, 318-268/12, 318-336/02, 318-336/04.
European nomenclature codes declared: P090804010202, P090804010102, P090803010102, P090903020202, P090804030101, P090903020201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Waldemar Link GmbH & Co. KG (DE) · FDA 3004371426 |
| Devices in EUDAMED | 2 068 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 2 068 |
|---|---|
| Found in the U.S. device database | 1 096 |
| Share | 53.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Waldemar Link GmbH & Co. KG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
20637GB450260728 | issued | 2031-07-27 |
20625GB450260722 | issued | 2031-07-21 |
20624GB450260507 | issued | 2031-05-06 |
20623GB450260709 | issued | 2031-07-08 |
20619GB450260504 | issued | 2031-05-03 |
20609GB450251216 | issued | 2030-12-15 |
20399GB450240517 | issued | 2029-05-16 |
20271GB450220502 | issued | 2027-05-01 |