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: Articulating surface, UHMWPE, fixed bearing PS, Articulating surface, UHMWPE, fixed bearing CR, Prosthesis head, uncemented, CoCrMo, 12/14 taper, Articulating surface, UHMWPE, mobile bearing, Bipolar head, uncemented, CoCrMo, UHMWPE.
Among these devices, 2 068 are declared sterile, 2 068 implantable.
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 register | Registered with FDA |
|---|---|
| Matched entry | Waldemar Link GmbH & Co. KG (DE) · FDA 3004371426 |
| Devices in EUDAMED | 2 068 |
| Country of registration | Germany |
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 |