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Vertebral Forming Unitized Surgical Instruments and Vertebroplasty Toolkit
EUDAMEDClass IIa (EU MDR)
Ref -Model Vertebral Forming Unitized Surgical Instruments: 201,202,203; Vertebroplasty Toolkit: ZC01,ZC02,ZC03,ZC04,ZC05,ZC06
Ref 201EModel 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
- Vertebral Forming Unitized Surgical Instruments EUDAMED
- Device Name
- Vertebral Forming Unitized Surgical Instruments and Vertebroplasty Toolkit EUDAMED
- Model / Reference
- Vertebral Forming Unitized Surgical Instruments: 201,202,203; Vertebroplasty Toolkit: ZC01,ZC02,ZC03,ZC04,ZC05,ZC06 EUDAMED- EUDAMEDVertebral 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. EUDAMED201E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69394885000APSCR EUDAMED06939488524774 EUDAMED
- Basic UDI-DI
- B-69394885000APSCR EUDAMED69394885000APS 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
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vertebral Forming Unitized Surgical Instruments and Vertebroplasty Toolkit by Dragon Crown Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED
Manufacturer's product page: Vertebral Forming Unitized Surgical Instruments Vertebroplasty Toolkit
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-69394885000APSCR | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-69394885000APSCR | 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 (2)
- EUDAMED 92587d45-cc95-4821-9e25-c45d9c50c40f 61 fields · synced Oct 6, 2026
- EUDAMED 77b76489-512d-46b1-bc28-7537109d5fa0 61 fields · synced Jul 14, 2026