Intelligent Breast Ultrasound Scanner

EUDAMED

Class IIa (EU MDR)

Ref IBUS 60Model IBUS 60G, IBUS 60, IBUS 30G, IBUS 30

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Device Name: Intelligent Breast Ultrasound Scanner EUDAMED
Model / Reference: IBUS 60G, IBUS 60, IBUS 30G, IBUS 30 EUDAMED
IBUS 60 EUDAMED

Identifiers

Primary DI / UDI-DI: 06938396406004 EUDAMED
Basic UDI-DI: 69383964002000220200000KW 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

Intelligent Breast Ultrasound 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	69383964002000220200000KW	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 5cca011a-a14b-49f6-b17d-6ebe2706c2d0 61 fields · synced Oct 7, 2026