Identity
- Trade Name
- kompres Warm-Koud EUDAMED
- Device Name
- Hot/Cold Packs EUDAMED
- Model / Reference
- GELO-PN-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945397912182 EUDAMED
- Basic UDI-DI
- 69453979-0-HotColdPackVQ 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
kompres Warm-Koud 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-HotColdPackVQ | 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 232f45fb-818b-4209-87dc-423b3f55b90a 61 fields · synced Jun 18, 2026