TX eco Cable
by Biosense Webster, Inc United States EUDAMED
Ref D140103Model TX eco Cable
EMDN Z12059080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3903009CE01 | Date1 Sep 2026 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR Withdrawn
Certificates
- 3903009CE01 Reissued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 1 Sep 2026
- Expires
- 1 Sep 2031
Specification
- Model / Reference
- TX eco Cable, D140103
- Primary DI / UDI-DI
- 10846835033199
- Basic UDI-DI
- 08468350a0025F5
- Direct Marketing DI
- 10846835033199
- EMDN Code
- Z12059080 Various instruments for cardiology and cardiac surgery - hardware accessories
- Device Class
- Class IIb
Manufacturer details
- EUDAMED SRN
- US-MF-000014219
- Authorised representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Other devices from Biosense Webster Inc
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 24b3ac31-dcfb-4418-847f-77ad6f314461