Identity
- Device Name
- Cool Gel Mats EUDAMED
- Model / Reference
- CGM0616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945397914452 EUDAMED
- Basic UDI-DI
- 69453979-0-CoolGelMat5H EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Cool Gel Mats by Jiangsu Intco Medical Products 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 | 69453979-0-CoolGelMat5H | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Intco Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000016338
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 3ac3ed78-fed4-44f1-8d03-7bbdee1e00c0 61 fields · synced Jul 30, 2026