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Transverse Frame

EUDAMED

Class I (EU MDR)

Ref LG29310Model QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ

by Dragon Crown Medical Co., Ltd.

Identity

Trade Name
Transverse Frame EUDAMED
Device Name
Expandable Retractor EUDAMED
Model / Reference
QK-Ⅰ, QK-Ⅱ, QK-Ⅲ, QK-Ⅳ, QK-Ⅴ, QK-Ⅵ EUDAMED
LG29310 EUDAMED

Identifiers

Primary DI / UDI-DI
06939488593428 EUDAMED
Basic UDI-DI
69394885000CPW EUDAMED
Direct Marketing DI
06939488593428 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

Transverse 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

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Manufacturer

EUDAMED SRN
CN-MF-000032712
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED e7631c9d-e5bb-4848-94ae-bef4b8dc397f 61 fields · synced Jul 26, 2026