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Expandable Retractor
EUDAMEDClass I (EU MDR)
Ref /Model QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ
Identity
- Device Name
- Expandable Retractor EUDAMED
- Model / Reference
- QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488593343 EUDAMED
- Basic UDI-DI
- 69394885000CPW EUDAMED
- Direct Marketing DI
- 06939488593343 EUDAMED
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Expandable Retractor by Dragon Crown Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Expandable Retractor
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 5e05cc43-0f52-4959-a085-3e0d189d6b1b 61 fields · synced Oct 7, 2026