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Multi-frequency Endocavitary Ultrasound Probe

EUDAMED

Class IIa (EU MDR)

Ref V6L11KModel V6L11K, V6LF, V5H11, V6L11A, V6L11G, V6L11C

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Device Name
Multi-frequency Endocavitary Ultrasound Probe EUDAMED
Model / Reference
V6L11K, V6LF, V5H11, V6L11A, V6L11G, V6L11C EUDAMED
V6L11K EUDAMED

Identifiers

Primary DI / UDI-DI
06938396493042 EUDAMED
Basic UDI-DI
693839640010042975K00008D EUDAMED
EMDN Code
Z11040299 ULTRASOUND PROBES – OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Multi-frequency Endocavitary Ultrasound Probe by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — CE/MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000010834
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 54072bf3-fe65-4404-94ca-e82891f491ef 61 fields · synced Oct 7, 2026