SINO Hook
by Shandong Weigao Orthopaedic Device Company Limited. 3 variants
Ref 800460003Model WGB1Z-1
Active
CE MDR
Valid until
7 Apr 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberM.2025.MDR.2024 | Date22 May 2026 | StatusActive |
Certificates
- M.2025.MDR.2024 Active
Technical documentation EU MDR
- Certifier
- UDEM Adriatic d.o.o. 2696
- Issued
- 22 May 2026
- Expires
- 7 Apr 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SINO Hook
- Model / Reference
- WGB1Z-1, 800460003
- Primary DI / UDI-DI
- 06939488338944
- Basic UDI-DI
- 6903095SPIWGB1Z1HK55
- EMDN Code
- P09070302 Thoracolumbosacral fixation systems
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000019785
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shandong Weigao Orthopaedic Device Company Limited.
See all devices from Shandong Weigao Orthopaedic Device Company Limited. →
Properties
Other properties (12)
- Sterile: 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