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Diagnostic Ultrasound Device

EUDAMED

Class IIa (EU MDR)

Ref DW-L6Model DW-L90, DW-L80, DW-L60, DW-L50, DW-L30, DW-L9, DW-L8, DW-L6, DW-L5, DW-L3

by Dawei Medical (Jiangsu) Co., Ltd.

Identity

Trade Name
Diagnostic Ultrasound Device EUDAMED
Device Name
Diagnostic Ultrasound Device EUDAMED
Model / Reference
DW-L90, DW-L80, DW-L60, DW-L50, DW-L30, DW-L9, DW-L8, DW-L6, DW-L5, DW-L3 EUDAMED
DW-L6 EUDAMED

Identifiers

Primary DI / UDI-DI
06972125711045 EUDAMED
Basic UDI-DI
697212571A00398 EUDAMED
Direct Marketing DI
06972125711045 EUDAMED
EMDN Code
Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Diagnostic Ultrasound Device by Dawei Medical (Jiangsu) Co., Ltd. — Class IIa — 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-000025846
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

  • EUDAMED ca08b710-5ce4-41c6-9536-28f614af7b12 61 fields · synced Jun 18, 2026