Kirchner & Wilhelm GmbH + Co KG
DE-MF-000006338 · Germany · Asperg
Kirchner & Wilhelm GmbH + Co KG is registered in the European database on medical devices as a manufacturer, with 287 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 287 |
|---|
Among these devices, 265 are declared active, 22 with a measuring function.
Devices declared under this manufacturer
- COMBILIGHT F.O.30 LED high power otoscope, 3.5 V
- Cuff A3, black, 2 tubes large adult
- Disposable Macintosh blade plastic, no. 3, non sterile
- F.O. MEGALIGHT Macintosh blade, no. 2
- F.O. MEGALIGHT Macintosh blade, no. 5
- F.O. Miller blade, no. 00
- F.O. Tepro Macintosh blade, no. 3
- KaWe EUROLIGHT PRO-SET LED ophthalmoscope and otoscope
- MASTERMED A1
- PICCOLIGHT E55, 2.5V ophthalmoscope, sky, 5 diaphragms
- PICCOLIGHT E56, HL, US ophthalmoscope head, only, night
- Reusable ear funnels, Ø 2.5 mm, 10 pcs.
Showing 12 of 287 declared devices.
Catalogue references include 01.12830.101, 01.72212.001, 01.87566.021, 03.12030.632, 03.14010.632, 03.42073.631.
European nomenclature codes declared: Z12021003, Z12021007, Z12021007,Z12120114, Z12120114, C9006, Z12040199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Kirchner & Wilhelm GmbH + Co.KG (DE) · FDA 8010427 |
| Devices in EUDAMED | 287 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 287 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 7.3 % |
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. Kirchner & Wilhelm GmbH + Co KG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-002 | issued | 2028-09-26 |