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Kedley Wrist Support
EUDAMEDClass I (EU MDR)
Ref KED012Model Kedley Support & Compression Range
Identity
- Trade Name
- Kedley Wrist Support EUDAMED
- Device Name
- Kedley Support & Compression Devices EUDAMED
- Model / Reference
- Kedley Support & Compression Range EUDAMEDKED012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06003058068125 EUDAMED
- Basic UDI-DI
- 60030580KED100VM EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Yes
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 Wrist 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 73cef3b8-8f4e-439c-b3a5-318c462f8d83 61 fields · synced Jul 10, 2026