ARKA, EUROPE, S.A.
PT-MF-000004547 · Portugal · Cruz, Vila Nova de Famalicão
ARKA, EUROPE, S.A. is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 45 |
|---|
Most frequent device types declared: Absorbent Underpads, Clip Cap in Polypropylene, Dental Bibs, Ginecological Exam Skirt, Latex Examination Gloves.
Devices declared under this manufacturer
- GRIM
- Golden Touch
- Nexderma
- Rubbergold
- Touca Clip em Polipropileno Azul
- Touca Clip em Polipropileno Branco
- Touca clip em Polipropileno Verde
Showing 12 of 45 declared devices.
Catalogue references include 2501-M, 2520-L, 2532-S, 2570-M, 3210, 4122.
European nomenclature codes declared: T01020204, T04010201, T010201, T0207, T020604, T0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 45 |
| Country of registration | Portugal |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 45 |
|---|---|
| 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. ARKA, EUROPE, S.A. was not found in either the U.S. or the Canadian register.