Custom Surgical GmbH
DE-MF-000034959 · Germany · München
Custom Surgical GmbH is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- Beamsplitter
- MicroREC
- MicroREC 3D
Catalogue references include BSH, BSL, LD3, LD4, LD5, MRC.
European nomenclature codes declared: Q0299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CUSTOM SURGICAL GMBH (DE) · FDA 3027240394 |
| Devices in EUDAMED | 12 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. Custom Surgical GmbH is registered in the United States but was not found in the Canadian register.