Optical Coherence Tomographer

by Shenzhen CERTAINN Technology Co., Ltd. EUDAMED 3 variants

Active European Union

Ref 507CP0002Model Mocean 3000

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06972039970156 Basic UDI-DI	Date27 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name: Optical Coherence Tomographer
Model / Reference: Mocean 3000, 507CP0002

Primary DI / UDI-DI: 06972039970156
Basic UDI-DI: B-06972039970156
EMDN Code: Z12120121 Optical consistency tomographs

Device Class: Class IIa
Market of Registration: France

Manufacturer details

EUDAMED SRN: CN-MF-000016915
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Measuring Function

Other properties (10)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Incorporates Medicinal Product: No