Identity
- Trade Name
- Edema Glove Silicone RT/XS EUDAMED
- Device Name
- Edema Glove Silicone EUDAMED
- Model / Reference
- 906 EUDAMED906XSR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032907810 EUDAMED
- Basic UDI-DI
- 73400329906M9 EUDAMED
- EMDN Code
- Y060606 HAND ORTHOSES 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
Edema Glove Silicone RT/XS by Mediroyal Nordic 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 | 73400329906M9 | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 202926f5-3ddc-4ffc-b56c-8d8f54538626 61 fields · synced Jun 18, 2026