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Intramedullary Nail System
EUDAMEDClass IIb (EU MDR)
Ref 15085032Model SJG-II
by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Identity
- Trade Name
- Intramedullary Nail System EUDAMED
- Device Name
- Intramedullary Nail System EUDAMED
- Model / Reference
- SJG-II EUDAMED15085032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937115493547 EUDAMED
- Basic UDI-DI
- 697035671SJG-IILN 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
Intramedullary Nail System by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697035671SJG-IILN | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000043758
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED f07b975d-c397-4736-aa2a-2e000452e52c 61 fields · synced Aug 3, 2026