Identity
- Trade Name
- Heel Wedge M EUDAMED
- Device Name
- Heel Wedge EUDAMED
- Model / Reference
- MR1401 EUDAMEDMR14010005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032900057 EUDAMED
- Basic UDI-DI
- 73400329MR14016A EUDAMED
- Direct Marketing DI
- 07340032900057 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Heel Wedge M by Mediroyal Nordic AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 73400329MR14016A | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 0f4335af-6914-43a5-ac1e-cd36db0979e8 61 fields · synced Jul 9, 2026