Identity
- Trade Name
- ThermaCare EUDAMED
- Device Name
- ThermaCare (for Knee pain 8 hours) EUDAMED
- Model / Reference
- F00573304017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08000036026809 EUDAMED
- Basic UDI-DI
- 08600065397TC8KE8000000QT EUDAMED
- Unit of Use DI
- 08000036028810 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
ThermaCare by Angelini Pharma Inc. — 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 | 08600065397TC8KE8000000QT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Angelini Pharma Inc.
- EUDAMED SRN
- US-MF-000038346
- Authorised Representative
- Angelini Pharma S.p.A. IT-AR-000028426
Sources (1)
- EUDAMED 31dfd843-1305-4983-a959-69b7fe60a0be 61 fields · synced Jun 17, 2026