Pharmacool
Part of a family of 24 devices: see the family page
Ref ICE150230
Pharmacool (ICE150230) is a Class IIa device made by Pharmaplast, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 62220238ThermaPatchRR) with CE/MDR certificate 2025-MDR/QS-072 valid until 24 Nov 2030, active as of 24 Oct 2026.
Active
CE MDR
Valid until
24 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number62220238ThermaPatchRR 06221329007172 | Date8 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 62220238ThermaPatchRR
Certificates
- 2025-MDR/QS-072 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 24 Nov 2025
- Expires
- 24 Nov 2030
Timeline
- Certificate issued EUDAMED 2025-MDR/QS-072
- Registered EUDAMED 62220238ThermaPatchRR
- Certificate expires EUDAMED 2025-MDR/QS-072
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Thermoregulating pads
- Model / reference
- ICE150230
- Primary DI / UDI-DI
- 06221329007172
- Basic UDI-DI
- 62220238ThermaPatchRR
- EMDN code
- M9001 Cryotherapy and thermotherapy devices
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- EG-MF-000004501
- Authorised representative
- E C REP LIMITED IE-AR-000003995
Similar devices in this category
Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.