Identity
- Trade Name
- Thermcool&hot EUDAMED
- Device Name
- HOT COLD GEL PACK EUDAMED
- Model / Reference
- BCF001016 EUDAMEDBCF001009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03614790001016 EUDAMED03614790001009 EUDAMED
- Basic UDI-DI
- 8017990BCFEL EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Thermcool&hot by Eurosirel Spa — 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 | 8017990BCFEL | Class I | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (2)
- EUDAMED e8b02e5e-2688-408b-b32f-2c515f74714f 61 fields · synced Sep 18, 2026
- EUDAMED 4ea7cb5c-c72a-4067-800a-1cf9ea1b7e8c 61 fields · synced May 18, 2026