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Kedley Hot/Cold Therapy
EUDAMEDClass I (EU MDR)
Ref KED065Model Kedley Support & Compression Range
Identity
- Trade Name
- Kedley Hot/Cold Therapy EUDAMED
- Device Name
- Kedley Support & Compression Devices EUDAMED
- Model / Reference
- Kedley Support & Compression Range EUDAMEDKED065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06003058078407 EUDAMED
- Basic UDI-DI
- 60030580KED100VM EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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
Category: Hot/cold therapy pack, reusable
Kedley Hot/Cold Therapy by Impo International Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 d14b091a-8c50-4c84-8172-f9f8cc9c0190 61 fields · synced Jun 19, 2026