Identity
- Trade Name
- Kalt&Warm Kompressen EUDAMED
- Device Name
- Hot/Cold Packs EUDAMED
- Model / Reference
- GELO-PN-130 EUDAMEDGELO-PN-260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945397911970 EUDAMED06945397911987 EUDAMED06945397912007 EUDAMED
- Basic UDI-DI
- 69453979-0-HotColdPackVQ EUDAMED
- Direct Marketing DI
- 06945397911963 EUDAMED06945397911994 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
Kalt&Warm Kompressen 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 (3)
- EUDAMED 9568e4c2-5a97-41b9-abd6-126a79a2bec0 61 fields · synced Jul 17, 2026
- EUDAMED 5df0af8d-518b-4020-b4ce-ab3f6a608a1b 61 fields · synced May 18, 2026
- EUDAMED e867cd4a-bec2-4ae1-a679-c730a555da7b 61 fields · synced May 18, 2026