Simpass
by Simeks Tibbi Urunler San. ve Tic LTD STI 241 variants
Ref PS20010-TModel 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- M.2025.MDR.1088-1 Withdrawn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- Withdrawn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, PS20010-T
- Primary DI / UDI-DI
- 08699343603911
- 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