Simpass
by Simeks Tibbi Urunler San. ve Tic LTD STI 241 variants
Part of a family of 144 devices: see the family page
Ref PS15018Model Simpass Plus
Simpass (PS15018) is a Class III device made by Simeks Tibbi Urunler San. ve Tic LTD STI, registered in EUDAMED on 15 Oct 2024 (Basic UDI-DI 86993436PTCASC89) with CE/MDR certificate M.2025.MDR.1088-1 valid until 10 Nov 2028, withdrawn as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberM.2025.MDR.1088-1 | Date11 Nov 2025 | StatusWithdrawn |
Official records
- EUDAMED public site 86993436PTCASC89
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- M.2025.MDR.1088-1 Withdrawn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
Timeline
- Registered EUDAMED 86993436PTCASC89
- Certificate issued EUDAMED M.2025.MDR.1088-1
- Certificate expires EUDAMED M.2025.MDR.1088-1
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- Withdrawn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, PS15018
- Primary DI / UDI-DI
- 08699343604215
- Basic UDI-DI
- 86993436PTCASC89
- EMDN code
- C010401020101 Ptca balloon dilation catheters
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000015871
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