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Snapshot 2026-10-13 · Link to EUDAMED

Digital Color Doppler Ultrasound Imaging Scanner

UDI-DI 06938396455002Basic UDI-DI 69383964001002207300000PD

Class IIa · MDR · Shantou Institute of Ultrasonic Instruments Co., Ltd.

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Identification

Model: Apogee 1000, Apogee 1100Diamond, Apogee 1100Lite, Apogee 1000Neo, Apogee 1000Lite, Apogee 1000Pro, Apogee 1000Ace, CTS-5500, CTS-6600, Apogee 2000
EMDN: Z11040199
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-13 · Link to EUDAMED

Manufacturer

Shantou Institute of Ultrasonic Instruments Co., Ltd.

SRN CN-MF-000010834

CN · Shantou, Guangdong

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/digital-color-doppler-ultrasound-imaging-scanner-5002 · UDI page: /udi/06938396455002

All devices from Shantou Institute of Ultrasonic Instruments Co., Ltd.

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