Identity
- Trade Name
- Cold/hot pack + hip brace EUDAMED
- Device Name
- Cold/Hot Pack EUDAMED
- Model / Reference
- KK-CH-720g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974423590087 EUDAMED
- Basic UDI-DI
- 697442359RPAUM EUDAMED
- Direct Marketing DI
- 06974423590087 EUDAMED
- EMDN Code
- M030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 + hip brace by Koolcare Technology Co., Ltd. — 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 | 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 (1)
- EUDAMED e9a077a6-3248-476e-ba92-1042e94b337e 61 fields · synced Jun 18, 2026