Simvalve
by Simeks Tibbi Urunler San. ve Tic LTD STI 130 variants
Ref SVX2660Model Simvalve Flex
Active
CE MDR
Valid until
31 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number86993436PTVSCA8 08699343626415 | Date3 Sep 2026 | StatusActive |
Certificates
- MDR.2292-2026/0067 Active
Technical documentation EU MDR
- Certifier
- UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
- Issued
- 1 Sep 2026
- Expires
- 31 Aug 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Simvalve Flex PTV Balloon Catheter
- Model / Reference
- Simvalve Flex, SVX2660
- Primary DI / UDI-DI
- 08699343626415
- Basic UDI-DI
- 86993436PTVSCA8
- EMDN Code
- C019014 Cardiac valvuloplasty catheters
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TR-MF-000015871
Other devices from Simeks Tibbi Urunler San. ve Tic LTD STI
See all devices from Simeks Tibbi Urunler San. ve Tic LTD STI →
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