Identity
- Trade Name
- Pharmacool EUDAMED
- Device Name
- Thermoregulating pads EUDAMED
- Model / Reference
- ICE130150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223003730864 EUDAMED
- Basic UDI-DI
- 62220238ThermaPatchRR 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
Pharmacool by Pharmaplast — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 | 62220238ThermaPatchRR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 0a549ba2-2fbc-43e7-a1bb-ad18e55aabf7 61 fields · synced Aug 4, 2026