Sapphire II NC
by OrbusNeich Medical (Shenzhen) Co., Ltd 60 variants
Ref 117-3518J
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The Sapphire II NC Coronary Dilatation Catheter is a high-quality medical device designed for safe and effective treatment of coronary artery disease. Developed by OrbusNeich Medical (Shenzhen) Co.,Ltd, this device has undergone rigorous testing and evaluation to ensure its reliability and performance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06934955929403 06934955929403 | Date23 Dec 2021 | 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- Withdrawn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
- 117-3518J
- Primary DI / UDI-DI
- 06934955929403
- Basic UDI-DI
- B-06934955929403
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Italy
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 (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No