Guide Wire
by Dragon Crown Medical Co., Ltd. 4 variants
Ref LG08282Model 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.
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69394885000APS 06939488524743 | Date12 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Vertebral Forming Unitized Surgical Instruments and Vertebroplasty Toolkit
- 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., LG08282
- Primary DI / UDI-DI
- 06939488524743
- Basic UDI-DI
- 69394885000APS
- EMDN Code
- P099002 Orthopaedic cement preparation and application devices and kits
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000032712
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Dragon Crown Medical Co., Ltd.
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No