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LOW Lateral Orthotic Wedge Insoles 34/35
EUDAMEDClass I (EU MDR)
Ref MR17000002Model MR1700
Identity
- Trade Name
- LOW Lateral Orthotic Wedge Insoles 34/35 EUDAMED
- Device Name
- LOW Lateral Orthotic Wedge Insoles EUDAMED
- Model / Reference
- MR1700 EUDAMEDMR17000002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032909517 EUDAMED
- Basic UDI-DI
- 73400329MR17006P 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
LOW Lateral Orthotic Wedge Insoles 34/35 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 | 73400329MR17006P | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 18cee297-fe45-4c77-8958-38864767a860 61 fields · synced Jun 18, 2026