ThermaPatch Adhesive
Ref THPADH95300
Active
CE MDR
Valid until
24 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number62220238ThermaPatchRR 06222023899797 | Date8 Jun 2026 | StatusActive |
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
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Thermoregulating pads
- Model / Reference
- THPADH95300
- Primary DI / UDI-DI
- 06222023899797
- Basic UDI-DI
- 62220238ThermaPatchRR
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- EG-MF-000004501
- Authorised representative
- E C REP LIMITED IE-AR-000003995
Other devices from Pharmaplast
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No