Identity
- Trade Name
- Dr. Max Cooling Patches EUDAMED
- Device Name
- Cooling Patch EUDAMED
- Model / Reference
- KK-CE-06 EUDAMEDKK-II-CP-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595566432508 EUDAMED08595566429997 EUDAMED
- Basic UDI-DI
- 697442359CP12KD 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 Cooling Patches 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 | 697442359CP12KD | 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 (2)
- EUDAMED a59b5b53-8fd6-4581-89a2-add736e47824 61 fields · synced Jul 14, 2026
- EUDAMED f1eb1682-69dc-4740-be58-525f5d9fe03b 61 fields · synced May 18, 2026