Black Forest Medical GmbH
DE-MF-000005752 · Germany · Freiburg im Breisgau
Black Forest Medical GmbH is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 138 |
|---|---|
| Class I | 39 |
Among these devices, 9 are declared sterile, 43 reusable.
Devices declared under this manufacturer
- DORO COBRA® Flexible Rotary Arm 280 mm
- DORO LUCENT® Parallelogram Adaptor BAXTER for SIEMENS Aera/Skyra MRI S
- DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Otesus+Alpha
- DORO® Blade, 102 x 26 mm
- DORO® Blade, Black Coated, 152 x 13 mm
- DORO® Blade, Black Coated, 152 x 16 mm
- DORO® Easy-Connect Navigation Adaptor, STRYKER
- DORO® Flexible Arm 230 mm
- DORO® Halo Ring
- DORO® Halo Support Rod Holder
- DORO® Head Support
- DORO® QR3 Skull Clamp Teflon
Showing 12 of 177 declared devices.
Catalogue references include 1201.006, 1204.001, 3020-03, 3110-01, 3114-34, 3116-13.
European nomenclature codes declared: Z12109080, L1102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Black Forest Medical GmbH (DE) · FDA 3003923584 |
| Devices in EUDAMED | 177 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 177 |
|---|---|
| Found in the U.S. device database | 168 |
| Share | 94.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BLACK FOREST MEDICAL GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2007-01-23 |
Licence types: Device Family (2).
Licensed under: SKULL PINS (STAINLESS STEEL), DORO DISPOSABLE TITANIUM SKULL PINS.
North American profile: Both markets. Black Forest Medical GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000297665 | supplemented | 2028-07-05 |
1000297641 | supplemented | 2029-03-21 |