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Longitudinal Long Frame
EUDAMEDClass I (EU MDR)
Ref LG29329Model QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ
Identity
- Trade Name
- Longitudinal Long Frame EUDAMED
- Device Name
- Expandable Retractor EUDAMED
- Model / Reference
- QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ EUDAMEDLG29329 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488593466 EUDAMED
- Basic UDI-DI
- 69394885000CPW EUDAMED
- Direct Marketing DI
- 06939488593466 EUDAMED
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Longitudinal Long Frame by Dragon Crown Medical Co., Ltd. — Class I — 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 | 69394885000CPW | Class I | 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 42013d2e-123f-4062-97b6-1513bc9f5010 61 fields · synced Jul 30, 2026