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Retractor Tube
EUDAMEDClass I (EU MDR)
Ref LG29323Model QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-ⅥRef LG29324Ref LG29322Ref LG29325
Identity
- Trade Name
- Retractor Tube EUDAMED
- Device Name
- Expandable Retractor EUDAMED
- Model / Reference
- QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ EUDAMEDLG29323 EUDAMEDLG29324 EUDAMEDLG29322 EUDAMEDLG29325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488593381 EUDAMED06939488593398 EUDAMED06939488593374 EUDAMED06939488593404 EUDAMED
- Basic UDI-DI
- 69394885000CPW EUDAMED
- Direct Marketing DI
- 06939488593381 EUDAMED06939488593398 EUDAMED06939488593374 EUDAMED06939488593404 EUDAMED
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDTürkiye 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
Retractor Tube 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 (5)
- EUDAMED 5e2204b3-fbc0-489d-a117-a1447e6582e8 61 fields · synced Oct 6, 2026
- EUDAMED 60de7421-8130-4bb0-9e85-701091fd572a 61 fields · synced May 18, 2026
- EUDAMED f800c875-3c9b-42a1-b6fc-4b9bf8b83915 61 fields · synced May 18, 2026
- EUDAMED fa60a7f2-917e-4ffb-81f1-ccf709bc9744 61 fields · synced Jul 11, 2026
- EUDAMED c91fdd19-877b-48e1-9ec4-8e81c30f0c87 61 fields · synced Jul 22, 2026