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Gloss® 520
EUDAMEDClass I (EU MDR)
Ref 1649835Ref 1655082Ref 1654860Ref 1638417Ref 1654630
Identity
- Trade Name
- Gloss® 520 EUDAMED
- Device Name
- Gloss® EUDAMED
- Model / Reference
- 1649835 EUDAMED1655082 EUDAMED1654860 EUDAMED1638417 EUDAMED1654630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07331492594245 EUDAMED07331492596034 EUDAMED07331492595952 EUDAMED07331492593651 EUDAMED07331492595518 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® 520 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 (5)
- EUDAMED a4d54465-b53a-4287-a46a-ca5f751b5320 61 fields · synced Jul 22, 2026
- EUDAMED b36b6bcf-730d-453b-a423-e97180a1ce05 61 fields · synced May 18, 2026
- EUDAMED c7a752ad-79ed-4c64-a1ef-9a0d62790eee 61 fields · synced May 18, 2026
- EUDAMED e266ff1a-6654-4a5a-9371-f4f87129df71 61 fields · synced May 18, 2026
- EUDAMED 81b75fc3-355e-4858-97db-4ff067cc2fb7 61 fields · synced May 18, 2026