Identity
- Device Name
- Cold/Hot Pack EUDAMED
- Model / Reference
- KK-RP-CH EUDAMEDKK-RP-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974423590049 EUDAMED06974423593507 EUDAMEDD-697442359RPAUMT5 EUDAMED
- Basic UDI-DI
- 697442359RPAUM EUDAMEDB-697442359RPAUMT5 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMEDGermany 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
Cold/Hot Pack by Koolcare Technology Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697442359RPAUM | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697442359RPAUM | Class I | Active |
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Manufacturer
- Manufacturer
- Koolcare Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017687
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (3)
- EUDAMED a9f1cde1-53fb-4d95-9bf2-ee1d8df8a18a 61 fields · synced Jul 26, 2026
- EUDAMED 7cfd523b-7853-4624-8b65-2210ea0457d7 61 fields · synced May 18, 2026
- EUDAMED 33dedf38-eccf-4064-b37b-3cbbf237c899 61 fields · synced May 19, 2026