Digital Color Doppler Ultrasound Imaging Scanner

EUDAMED

Class IIa (EU MDR)

Ref A32ExpModel A56Exp,A56,A56Pro,A56Lite,A52,A52Pro,A52Lite,A52Exp,A50,A50Pro,A50Lite,A50Exp,A36,A36Pro,A36Lite,A36Exp,A32,A32Pro,A32Lite,A32Exp,A30,A30Pro,A30Lite,A30Exp,A25,A25Pro,A25Lite,A25Exp,A22,A22Pro,A22Lite,A22Exp,A20,A20Pro,A20Lite,A20Exp

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Device Name: Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
Model / Reference: A56Exp,A56,A56Pro,A56Lite,A52,A52Pro,A52Lite,A52Exp,A50,A50Pro,A50Lite,A50Exp,A36,A36Pro,A36Lite,A36Exp,A32,A32Pro,A32Lite,A32Exp,A30,A30Pro,A30Lite,A30Exp,A25,A25Pro,A25Lite,A25Exp,A22,A22Pro,A22Lite,A22Exp,A20,A20Pro,A20Lite,A20Exp EUDAMED
A32Exp EUDAMED

Identifiers

Primary DI / UDI-DI: 06938396403737 EUDAMED
Basic UDI-DI: 693839640010012H1400000ZC EUDAMED
EMDN Code: Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Digital Color Doppler Ultrasound Imaging Scanner 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	693839640010012H1400000ZC	Class IIa	Active

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Manufacturer

Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd.
EUDAMED SRN: CN-MF-000010834
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

EUDAMED df065606-c89c-4df3-bae1-03b57fac379d 61 fields · synced Oct 6, 2026