Identity
- Trade Name
- AFO Dorsal Splint LT/S EUDAMED
- Device Name
- AFO Dorsal Splint EUDAMED
- Model / Reference
- MR5801 EUDAMEDMR05801100409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032935424 EUDAMED
- Basic UDI-DI
- 73400329MR58017S EUDAMED
- Direct Marketing DI
- 07340032935424 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
AFO Dorsal Splint LT/S 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 | 73400329MR58017S | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 70f04489-d05e-4a7b-8d6a-046f0a19add2 61 fields · synced Jul 20, 2026