Anita Dr. Helbig GmbH
DE-MF-000012631 · Germany · Brannenburg
Anita Dr. Helbig GmbH is registered in the European database on medical devices as a manufacturer, with 16 255 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 16 255 |
|---|
Devices declared under this manufacturer
- Bologna
- Clara Art
- Lisa
- Lynn
- Medellin
- Osaka
- Rosemary
- Safina
- Sophia
- Style Girona Top
- Style Krabi
- Style Santa Marta Top
Showing 12 of 16 255 declared devices.
Catalogue references include 5349X, 5706X, 5726X, 5763X, 5899, M0-6286.
European nomenclature codes declared: Y063099, M030499, Y063018.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ANITA DR. HELBIG GMBH (DE) · FDA 9680655 |
| Devices in EUDAMED | 16 255 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 16 255 |
|---|---|
| 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. Anita Dr. Helbig GmbH is registered in the United States but was not found in the Canadian register.