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Digital Color Doppler Ultrasound Imaging Scanner

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref Readius P8Model Readius L15, Readius P8, Readius V6, Readius C6

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Trade Name
SIUI FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
Digital Color Doppler Ultrasound Imaging System FDA UDI
Model / Reference
Readius L15, Readius P8, Readius V6, Readius C6 EUDAMED
Readius P8 EUDAMEDFDA UDI
Description
Digital Color Doppler Ultrasound Imaging System FDA UDI

Identifiers

Primary DI / UDI-DI
06938396401016 EUDAMEDFDA UDI
Basic UDI-DI
69383964001002228900000TJ EUDAMED
510(k) Number
K243132 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
EMDN Code
Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Digital Color Doppler Ultrasound Imaging Scanner by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA…

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 3676853a-76e2-4d33-acb4-1cad9222e895 61 fields · synced Jun 19, 2026
  • FDA UDI 2b195d30-1b58-4787-a941-08e170f50a2f 34 fields · synced May 30, 2026