Identity
- Trade Name
- Ice Bag EUDAMED
- Device Name
- ICE/HOT PACK EUDAMED
- Model / Reference
- TM504R-BL-M EUDAMEDTM504R-BL-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269539886 EUDAMED00840269539893 EUDAMED
- Basic UDI-DI
- 08402695CL1078Q EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Hot/cold therapy pack, reusable
Ice Bag by La Pointique Int´l Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 08402695CL1078Q | Class I | Active |
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Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 0bd4a5d1-9196-49ec-82e2-34d3789bfb44 61 fields · synced Jul 9, 2026
- EUDAMED 14ab1a7f-afa8-4e28-b29c-1f2df9a286b5 61 fields · synced May 19, 2026