Multi-frequency 4D Ultrasound Probe

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref C5LF

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Trade Name: SIUI FDA UDI
Generic Name: Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Device Name: Multi-frequency 4D Ultrasound Probe EUDAMED
Convex Array Transducer FDA UDI
Model / Reference: C5LF EUDAMEDFDA UDI
Description: Convex Array Transducer FDA UDI

Identifiers

Primary DI / UDI-DI: 06938396495053 EUDAMEDFDA UDI
Basic UDI-DI: 693839640010042846W0000AQ EUDAMED
Direct Marketing DI: 06938396495053 EUDAMED
FDA Product Code: ITX FDA UDI
EMDN Code: Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
GMDN Term: Extracorporeal ultrasound imaging transducer, hand-held FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Multi-frequency 4D Ultrasound Probe by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	693839640010042846W0000AQ	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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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 (2)

EUDAMED e66f2da0-2173-4a94-9b42-0dea3f753540 61 fields · synced Oct 7, 2026
FDA UDI fc1788d3-9884-4c4f-98e8-3f9ebc72c962 33 fields · synced May 30, 2026