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Kedley Arm Support
EUDAMEDClass I (EU MDR)
Ref KED043Model Kedley Support & Compression Range
Identity
- Trade Name
- Kedley Arm Support EUDAMED
- Device Name
- Kedley Support & Compression Devices EUDAMED
- Model / Reference
- Kedley Support & Compression Range EUDAMEDKED043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06003058068439 EUDAMED
- Basic UDI-DI
- 60030580KED100VM EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Kedley Arm Support by Impo International Limited — 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 | 60030580KED100VM | Class I | Active |
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Manufacturer
- Manufacturer
- Impo International Limited
- EUDAMED SRN
- GB-MF-000010073
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED b7ee2843-024e-41b1-96d1-425664a7fb49 61 fields · synced Jun 20, 2026