SkyLoach
by Skynor Medical(Shanghai)Co., Ltd 50 variants
Ref 07Model IB-2720
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-06970757200388 06970757200388 | Date8 Aug 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- Withdrawn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
- Device Name
- Intracranial Balloon Dilatation Catheter
- Model / Reference
- IB-2720, 07
- Primary DI / UDI-DI
- 06970757200388
- Basic UDI-DI
- B-06970757200388
- EMDN Code
- C019010 Intravascular recanalisation systems
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000028227
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Skynor Medical(Shanghai)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