Identity
- Device Name
- SINO Hook EUDAMED
- Model / Reference
- WGB1Z-1 EUDAMED800460001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488338920 EUDAMED
- Basic UDI-DI
- 6903095SPIWGB1Z1HK55 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Spinal bone screw, non-bioabsorbable
SINO Hook by Shandong Weigao Orthopaedic Device Company Limited. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6903095SPIWGB1Z1HK55 | Class III | Active |
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Manufacturer
- Manufacturer
- Shandong Weigao Orthopaedic Device Company Limited.
- EUDAMED SRN
- CN-MF-000019785
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fd2cba0d-68b6-47b9-91a2-9caad516d9f3 61 fields · synced Jul 19, 2026