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Bone Cement Injector
EUDAMEDClass IIa (EU MDR)
Ref LG08239Model Vertebral Forming Unitized Surgical Instruments: 201E, 202E, 203E,PN01,SP01,GW01, DT01, WC01, BN01, ID01, BI01, SD01, HD01, PR01, EX01; Vertebroplasty Toolkit: ZC01E, ZC02E, ZC03E, ZC06E.
Identity
- Trade Name
- Bone Cement Injector EUDAMED
- Device Name
- Vertebral Forming Unitized Surgical Instruments and Vertebroplasty Toolkit EUDAMED
- Model / Reference
- Vertebral Forming Unitized Surgical Instruments: 201E, 202E, 203E,PN01,SP01,GW01, DT01, WC01, BN01, ID01, BI01, SD01, HD01, PR01, EX01; Vertebroplasty Toolkit: ZC01E, ZC02E, ZC03E, ZC06E. EUDAMEDLG08239 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488524361 EUDAMED
- Basic UDI-DI
- 69394885000APS EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bone Cement Injector by Dragon Crown Medical Co., Ltd. — Class IIa — 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 | 69394885000APS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dragon Crown Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000032712
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c73a23c6-6982-4a43-a893-3d48e4da28a6 61 fields · synced Jul 10, 2026