Identity
- Trade Name
- Thermcool EUDAMED
- Device Name
- Ice spray EUDAMEDInstant ice pack EUDAMED
- Model / Reference
- GSAA30121389 EUDAMEDGIS000170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03401060121389 EUDAMED03614790000170 EUDAMED
- Basic UDI-DI
- B-03401060121389 EUDAMEDB-03614790000170 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Thermcool by Eurosirel Spa — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03401060121389 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (2)
- EUDAMED 9e0c4d42-3028-4515-9fc1-f52f2fccb02c 61 fields · synced Oct 6, 2026
- EUDAMED dc3d799a-b4fc-4f34-b906-6a8f135c9d94 61 fields · synced May 18, 2026