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Intramedullary Nail System
EUDAMEDClass IIb (EU MDR)
Ref 15724230Model SHG-I
by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Identity
- Trade Name
- Intramedullary Nail System EUDAMED
- Device Name
- Intramedullary Nail System EUDAMED
- Model / Reference
- SHG-I EUDAMED15724230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931712404463 EUDAMED
- Basic UDI-DI
- 697035671SHG-IKQ 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
Intramedullary Nail System by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697035671SHG-IKQ | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000043758
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7f3ce331-9432-40c6-b904-566918ca27ba 61 fields · synced Sep 18, 2026