← Back to catalogue
Puncture Needle
EUDAMEDClass IIa (EU MDR)
Ref LG08312Model 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
- Puncture Needle 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. EUDAMEDLG08312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488524705 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
Puncture Needle 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dragon Crown Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000032712
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 10b55791-1d01-43c2-8553-c6d92bb707fc 61 fields · synced Jul 9, 2026