Identity
- Trade Name
- ThermaCare EUDAMED
- Device Name
- ThermaCare (for Neck Shoulder and Wrist 12 hours) EUDAMED
- Model / Reference
- F00573300606W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08000036026441 EUDAMED
- Basic UDI-DI
- 08600065397TC6NSW120000JL EUDAMED
- Unit of Use DI
- 08000036028605 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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
Category: Hot/cold therapy pack, reusable
ThermaCare by Angelini Pharma Inc. — Class IIa — 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 | 08600065397TC6NSW120000JL | 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 1a554b9d-2cce-4aa0-907a-54bd85296fc3 61 fields · synced Jun 19, 2026