Cool Star
by G.M.S. Bi̇li̇şi̇m Elktroni̇k Medi̇kal Tibbi̇ Malzeme Ve Ci̇hazlar Teksti̇l İnşaat Ve Ti̇c. Ltd. Şti̇. 11 variants
Ref CS PAD-2
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number869995608CSPAD-2D2 08699956081120 | Date1 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cool Star
- Model / Reference
- CS PAD-2
- Primary DI / UDI-DI
- 08699956081120
- Basic UDI-DI
- 869995608CSPAD-2D2
- EMDN Code
- V80 Clinical use accessories not included in other classes
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000021954
Other devices from G.M.S. Bi̇li̇şi̇m Elktroni̇k Medi̇kal Tibbi̇ Malzeme Ve Ci̇hazlar Teksti̇l İnşaat Ve Ti̇c. Ltd. Şti̇.
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