Richard Wolf GmbH
DE-MF-000007048 · Germany · Knittlingen
Richard Wolf GmbH is registered in the European database on medical devices as a manufacturer, with 470 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 468 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: 10000201041, 10000201050, 10000201069, 10000201220, 10000201234.
Among these devices, 40 are declared reusable, 31 active.
Catalogue references include 8095.05, 8095.07, 8108035, 8217.12, 83930084, 85525812.
European nomenclature codes declared: Z12011399, Z12010980, L0406, Z12020499, Z12021199, A0799.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RICHARD WOLF GMBH (DE) · FDA 9611102 |
| Devices in EUDAMED | 470 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 470 |
|---|---|
| Found in the U.S. device database | 402 |
| Share | 85.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | RICHARD WOLF GMBH |
What it holds in Canada
| Licences on record | 103 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 97 |
| Class 3 devices | 6 |
| First licensed | 2001-10-05 |
Licence types: Device Family (57), System (31), Single Device (7), Device Group Family (6).
Licensed under: RIGID ENDOSCOPES WITH OPTICS, BIOPSY FORCEPS AND PUNCHES, INTRACORPOREAL ULTRASOUND LITHOTRIPTOR SYSTEM , RESECTOSCOPE SHEATHS, ELECTRODES, MONOPOLAR, MONOPOLAR ELECTROSURGICAL FORCEPS, SCISSORS AN.
North American profile: Both markets. Richard Wolf GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 012004 0017 | issued | 2031-06-25 |
50593-60-01-03 | issued | 2030-12-13 |