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Multi-frequency Endocavitary Ultrasound Probe

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref V6LC

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Trade Name
SIUI FDA UDI
Generic Name
Rectal/vaginal ultrasound imaging transducer FDA UDI
Device Name
Multi-frequency Endocavitary Ultrasound Probe EUDAMED
Endocavity Transducer FDA UDI
Model / Reference
V6LC EUDAMEDFDA UDI
Description
Endocavity Transducer FDA UDI

Identifiers

Primary DI / UDI-DI
06938396493172 EUDAMEDFDA UDI
Basic UDI-DI
693839640010042973W0000BP EUDAMED
Direct Marketing DI
06938396493172 EUDAMED
510(k) Number
K113613 FDA UDI
K160853 FDA UDI
K210318 FDA UDI
K243178 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
GMDN Term
Rectal/vaginal ultrasound imaging transducer 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The Multi-frequency Endocavitary Ultrasound Probe is a medical device designed for high-resolution imaging of the digestive system. Featuring advanced endocavitary technology, this probe provides detailed images of internal organs and tissues, allowing for accurate diagnosis and treatment. By leveraging multiple frequency ranges, it offers enhanced visualization capabilities, enabling clinicians to better understand complex anatomical structures.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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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 9bfa50c6-e43a-4866-b738-4635a832ca68 61 fields · synced Oct 6, 2026
  • FDA UDI 2eb74f04-64f3-476f-ab8f-55bcc5055655 34 fields · synced May 30, 2026