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Sterile and Non-Sterile Intramedullary Nailing System
EUDAMEDClass IIb (EU MDR)
Ref 412100000Model WGA1Z01
Identity
- Device Name
- Sterile and Non-Sterile Intramedullary Nailing System EUDAMED
- Model / Reference
- WGA1Z01 EUDAMED412100000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941689151772 EUDAMED
- Basic UDI-DI
- 6903095INSENC25 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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: Arthrodesis intramedullary nail, non-distracting
Sterile and Non-Sterile Intramedullary Nailing System by Shandong Weigao Orthopaedic Device Company Limited. — Class IIb — MDR — listed in EUDAMED
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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 | 6903095INSENC25 | Class IIb | 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 99c05811-31ae-4872-8772-369cafb11ba6 61 fields · synced Jun 19, 2026