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Digital Color Doppler Ultrasound Imaging Scanner

EUDAMED

Class IIa (EU MDR)

Ref Apogee 6300ProModel Apogee 6500/Apogee 6300/Apogee 6200/Apogee 6500Pro/Apogee 6300Pro/Apogee 6200Pro/Apogee 6500Ace/Apogee 6300Ace/Apogee 6200Ace/Apogee 5500Exp/Apogee 5500Pro/Apogee 5300Neo/Apogee 5300Pro

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Device Name
Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
Model / Reference
Apogee 6500/Apogee 6300/Apogee 6200/Apogee 6500Pro/Apogee 6300Pro/Apogee 6200Pro/Apogee 6500Ace/Apogee 6300Ace/Apogee 6200Ace/Apogee 5500Exp/Apogee 5500Pro/Apogee 5300Neo/Apogee 5300Pro EUDAMED
Apogee 6300Pro EUDAMED

Identifiers

Primary DI / UDI-DI
06938396400309 EUDAMED
Basic UDI-DI
6938396400112A6300000006Y EUDAMED
Direct Marketing DI
06938396400309 EUDAMED
EMDN Code
Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 (1)

  • EUDAMED 327872f7-2842-4ff1-b00c-bb41068c4f18 61 fields · synced Jun 19, 2026