Scoreflex Trio
by OrbusNeich Medical (Shenzhen) Co., Ltd 24 variants
Ref 633501511
Active
CE MDR
Valid until
24 May 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 762468 | Date18 Aug 2026 | StatusActive |
Certificates
- MDR 762468 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 18 Aug 2026
- Expires
- 24 May 2028
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Scoreflex TRIO Balloon Dilatation Catheter
- Model / Reference
- 633501511
- Primary DI / UDI-DI
- 06934955963209
- Basic UDI-DI
- 69349559631ZH
- Direct Marketing DI
- 06934955963209
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Spain
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
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