Identity
- Trade Name
- SOFORTKALTEKOMPRESSE EUDAMED
- Device Name
- Cold packs EUDAMED
- Model / Reference
- C127153NB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945397910454 EUDAMED06945397910461 EUDAMED
- Basic UDI-DI
- 69453979-0-ColdPackRU EUDAMED
- Unit of Use DI
- 06945397910423 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
Sofortkaltekompresse by Jiangsu Intco Medical Products Co., Ltd — Class IIa — 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-ColdPackRU | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 (2)
- EUDAMED 6a5727e1-efe3-41f0-9aa5-141d876cd352 61 fields · synced Jul 31, 2026
- EUDAMED 1a5a9f76-4a9c-4db9-9417-d9641b597c98 61 fields · synced May 19, 2026