Identity
- Trade Name
- Dr. Max Hot&Cold Therapy EUDAMED
- Device Name
- Cold/Hot Pack EUDAMED
- Model / Reference
- KK-CH-350g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595566425999 EUDAMED
- Basic UDI-DI
- 697442359RPAUM EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Dr. Max Hot&Cold Therapy 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 abe9796f-a5bd-4752-833a-532469551dc0 61 fields · synced Jun 19, 2026