Identity
- Trade Name
- Gloss® 680 EUDAMED
- Device Name
- Gloss® EUDAMED
- Model / Reference
- 1655054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07331492595976 EUDAMED
- Basic UDI-DI
- 7331226DolomiteGlossM3 EUDAMED
- EMDN Code
- Y120609 WALKING FRAMES WITH CHAIR, 4 WHEELS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Gloss® 680 by Invacare Rea AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7331226DolomiteGlossM3 | Class I | Active |
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Manufacturer
- Manufacturer
- Invacare Rea AB
- EUDAMED SRN
- SE-MF-000003772
Sources (1)
- EUDAMED 5ea2e8ef-994c-4af9-88ff-dd09c8ab4cf1 61 fields · synced Jul 13, 2026