Vital Signs Monitor

by Shenzhen Comen Medical Instruments Co., LTD. 13 variants

Ref OPUS i3Model NC5

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06945429020731 Basic UDI-DI 06945429020731UDI-DI	Date24 Apr 2022Registered	StatusActive

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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference: OPUS i3, NC5

Primary DI / UDI-DI: 06945429020731
Basic UDI-DI: B-06945429020731, 69454290SM001QB
Direct Marketing DI: 06945429020731
EMDN Code: Z12030299, Z1203020201

Device Class: Class IIb
EU market of registration: Belgium
Iceland

Manufacturer details

EUDAMED SRN: CN-MF-000002236
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties

Measuring Function

Other properties (12)

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