Erbe Elektromedizin GmbH
DE-MF-000005498 · Germany · Tübingen
Erbe Elektromedizin GmbH is registered in the European database on medical devices as a manufacturer, with 579 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 485 |
|---|---|
| Class IIa | 94 |
Among these devices, 99 are declared sterile, 503 active.
Devices declared under this manufacturer
- BiClamp® 201 T; MF-2
- Drahtschl.-Elek. Wolfr.; ø5mm
- ECO-LINE Elektrodengriff
- ERBE NESSY® Omega Plate
- Einsatz Bipolare LAP Schere
- NESSY® RePlate 200
- Nadelelektrode; ø 0,8x12mm
- Neutralelektroden Kabel
- Schlingenelek. Wolfr.; 6x15mm
- Schlingenelektr. Wolfr.; ø25mm
- Slim-Line Elektrodengriff E 4
- Spatelelektrode; 2,3x19mm
Showing 12 of 579 declared devices.
Catalogue references include 20190-065, 20190-112, 20193-083, 20193-090, 20194-079, 21191-151.
European nomenclature codes declared: L180601, L180401, L1899, K020180, K0201010301, Z12010902.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ERBE Elektromedizin GmbH (DE) · FDA 3009762450 |
| Devices in EUDAMED | 579 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 579 |
|---|---|
| Found in the U.S. device database | 106 |
| Share | 18.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ERBE ELEKTROMEDIZIN GMBH |
What it holds in Canada
| Licences on record | 21 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 13 |
| First licensed | 1999-12-07 |
Licence types: System (14), Device Family (4), Single Device (2), Device Group (1).
Licensed under: ELECTROSURGICAL CABLES AND ADAPTERS, ELECTROSURGICAL PATIENT PLATES, ERBOKRYO CA CRYOSURGICAL SYSTEM, APC300 ARGON PLASMA COAGULATION UNIT, ERBE APC 2 (FOR VIO) ARGON PLASMA COAGULATION , ERBE VIO 300 ELECTROSURGICAL SYSTEM.
North American profile: Both markets. Erbe Elektromedizin GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 015373 0010 | supplemented | 2031-07-12 |