Xtenza
by OrbusNeich Medical (Shenzhen) Co., Ltd China EUDAMED
Ref 570160251X
EMDN C0104010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69349559571ZQ | Date16 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 776474 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 18 Aug 2026
- Expires
- 18 Jun 2028
- Reason
- Change approved
Specification
- Device Name
- Xtenza Guide Catheter Extension
- Model / Reference
- 570160251X
- Primary DI / UDI-DI
- 06934955914959
- Basic UDI-DI
- 69349559571ZQ
- Direct Marketing DI
- 06934955914959
- EMDN Code
- C0104010202 Cardiac angiography guide catheters
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000011345
- Authorised representative
- Quality First International OÜ EE-AR-000004308
Other devices from OrbusNeich Medical (Shenzhen) Co., Ltd
See all devices from OrbusNeich Medical (Shenzhen) Co., Ltd →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 06934955914959|69349559571ZQ