Simpass
by Simeks Tibbi Urunler San. ve Tic LTD STI 241 variants
Part of a family of 67 devices: see the family page
Ref SNC22525Model Simpass NC HP
Simpass (SNC22525) is a Class III device made by Simeks Tibbi Urunler San. ve Tic LTD STI, registered in EUDAMED on 17 Nov 2025 (Basic UDI-DI 86993436PTCANC7S) with CE/MDR certificate M.2025.MDR.1088-1 valid until 10 Nov 2028, active as of 25 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 | Number86993436PTCANC7S 08699343615815 | Date17 Nov 2025 | StatusActive |
Official records
- EUDAMED public site 86993436PTCANC7S
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- M.2025.MDR.1088-1 Withdrawn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
- Certificate issued EUDAMED M.2025.MDR.1088-1
- Registered EUDAMED 86993436PTCANC7S
- Certificate expires EUDAMED M.2025.MDR.1088-1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Simpass NC HP RX PTCA Balloon Dilatation Catheter
- Model / reference
- Simpass NC HP, SNC22525
- Primary DI / UDI-DI
- 08699343615815
- Basic UDI-DI
- 86993436PTCANC7S
- 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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