Vivostat A/S
DK-MF-000019521 · Denmark · Alleroed
Vivostat A/S is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 |
|---|---|
| Class I | 14 |
Most frequent device types declared: APL 400, APL 404, AZ 220, GM 220, GM 740.
Among these devices, 21 are declared sterile, 3 reusable, 4 active.
Devices declared under this manufacturer
- Applicator Unit APL 400
- Applicator Unit APL 404 – Co-Delivery
- ArthroZheal® Arthroscopic Applicator Handle
- ArthroZheal® Set
- Obsidian® ASG Endoscopic Applicator Handle
- Obsidian® RFT Set
- Processor Unit PRO 800
- Vivostat® Endoscopic Kit
- Vivostat® Fibrin Set – Concorde
- Vivostat® Fibrin Set – Endoscopic
- Vivostat® PRF Set
- Vivostat® PRF Set – Co-Delivery
Showing 12 of 28 declared devices.
Catalogue references include APL 400, APL 404, AZ 220, GM 220, GM 740, PRO 800.
European nomenclature codes declared: A030499,B0599, A030499, L030199, B0599, B0502, A020199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 28 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 28 |
|---|---|
| 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: Neither register. Vivostat A/S was not found in either the U.S. or the Canadian register.