Identity
- Trade Name
- ROM Hinge 33 cm for Knee brace EUDAMED
- Device Name
- ROM Hinge 33 cm for Knee brace EUDAMED
- Model / Reference
- MR4998 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032909494 EUDAMED
- Basic UDI-DI
- 73400329MR49988Z EUDAMED
- Direct Marketing DI
- 07340032909494 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES 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
ROM Hinge 33 cm for Knee brace 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 | 73400329MR49988Z | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 8bc54dfc-9e02-42ee-a07e-f820c1c79465 61 fields · synced Jun 19, 2026