Simpass
by Simeks Tibbi Urunler San. ve Tic LTD STI 241 variants
Ref PS20035Model Simpass Plus
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberM.2025.MDR.1088-1 | Date11 Nov 2025 | StatusWithdrawn |
Certificates
- M.2025.MDR.1088-1 Withdrawn
Technical documentation EU MDR
- Certifier
- UDEM Adriatic d.o.o. 2696
- Issued
- 11 Nov 2025
- Expires
- 10 Nov 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Simpass Plus RX PTCA Balloon Dilatation Catheter
- Model / Reference
- Simpass Plus, PS20035
- Primary DI / UDI-DI
- 08699343609913
- Basic UDI-DI
- 86993436PTCASC89
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000015871
Other devices from Simeks Tibbi Urunler San. ve Tic LTD STI
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Properties
Other properties (12)
- 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