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Multi-frequency Linear-array Ultrasound Probe

EUDAMED

Class IIa (EU MDR)

Ref L10LFModel L10LF, L8LF

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Device Name
Multi-frequency Linear-array Ultrasound Probe EUDAMED
Model / Reference
L10LF, L8LF EUDAMED
L10LF EUDAMED

Identifiers

Primary DI / UDI-DI
06938396495107 EUDAMED
Basic UDI-DI
693839640010042983Y0000CW 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 Linear-array Ultrasound Probe by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — 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 d108a2b7-80f7-4c7f-92d8-231b0bd55d71 61 fields · synced Oct 6, 2026