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Digital Color Doppler Ultrasound Imaging Scanner

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref Apogee K3Model Apogee U5, Apogee U1, Apogee U2, Apogee U3, Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5

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
Apogee U5, Apogee U1, Apogee U2, Apogee U3, Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5 EUDAMED
Apogee K3 EUDAMEDFDA UDI
Description
Digital Color Doppler Ultrasound Imaging System FDA UDI

Identifiers

Primary DI / UDI-DI
06938396401399 EUDAMEDFDA UDI
Basic UDI-DI
69383964001002227100000PR EUDAMED
510(k) Number
K243178 FDA UDI
FDA Product Code
IYN FDA UDI
IYO 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
892.1550 FDA UDI
892.1560 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 7c3ccefb-964a-43d2-8694-02ae232949a3 61 fields · synced Oct 7, 2026
  • FDA UDI 48dbb818-c0a4-413f-8e1a-3b91073831e5 34 fields · synced May 30, 2026