THALIS Flex- Peripheral Stent Implantation System
by Q3 Medical Germany GmbH 25 variants
Ref 80 TFX 26-08 5F, 70 TFX 26-08 5F, 50 TFX 57-08 5F, 90 TFX 36-13 5F, 60 TFX 17-08 5F, 60 TFX 57-13 5F, 90 TFX 57-08 5F, 90 TFX 26-13 5F, 70 TFX 17-08 5F, 80 TFX 36-08 5F, 50 TFX 57-13 5F, 70 TFX 57-13 5F, 100 TFX 57-13 5F, 70 TFX 36-13 5F, 100 TFX 17-08 5F, 50 TFX 36-13 5F, 60 TFX 57-08 5F, 100 TFX 36-13 5F, 80 TFX 36-13 5F, 100 TFX 26-13 5F, 70 TFX 36-08 5F, 70 TFX 17-13 5F, 100 TFX 17-13 5F, 100 TFX 26-08 5F
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04051649251816 | Date1 Nov 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- 80 TFX 26-08 5F, 70 TFX 26-08 5F, 50 TFX 57-08 5F, 90 TFX 36-13 5F, 60 TFX 17-08 5F, 60 TFX 57-13 5F, 90 TFX 57-08 5F, 90 TFX 26-13 5F, 70 TFX 17-08 5F, 80 TFX 36-08 5F, 50 TFX 57-13 5F, 70 TFX 57-13 5F, 100 TFX 57-13 5F, 70 TFX 36-13 5F, 100 TFX 17-08 5F, 50 TFX 36-13 5F, 60 TFX 57-08 5F, 100 TFX 36-13 5F, 80 TFX 36-13 5F, 100 TFX 26-13 5F, 70 TFX 36-08 5F, 70 TFX 17-13 5F, 100 TFX 17-13 5F, 100 TFX 26-08 5F
- Primary DI / UDI-DI
- 04051649251816, 04051649251779, 04051649251717, 04051649252103, 04051649251724, 04051649251991, 04051649251878, 04051649252097, 04051649251762, 04051649251823, 04051649251953, 04051649252035, 04051649252158, 04051649252028, 04051649251885, 04051649251946, 04051649251755, 04051649252141, 04051649252066, 04051649252134, 04051649251786, 04051649252004, 04051649252127, 04051649251892
- Basic UDI-DI
- B-04051649251816, B-04051649251779, B-04051649251717, B-04051649252103, B-04051649251724, B-04051649251991, B-04051649251878, B-04051649252097, B-04051649251762, B-04051649251823, B-04051649251953, B-04051649252035, B-04051649252158, B-04051649252028, B-04051649251885, B-04051649251946, B-04051649251755, B-04051649252141, B-04051649252066, B-04051649252134, B-04051649251786, B-04051649252004, B-04051649252127, B-04051649251892
- EMDN Code
- P070402020102 Non-stainless steel peripheral vascular bare metal stents
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000008095
Other devices from Q3 Medical Germany GmbH
Properties
Other properties (11)
- 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