Medical Endoscopic Light Source

by Shenzhen Comen Medical Instruments Co., LTD. 3 variants

Ref LS-60BModel LS-60C

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69454290WS002T3 Basic UDI-DI 06945429028515UDI-DI	Date25 Dec 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: LS-60C, LS-60B

Primary DI / UDI-DI: 06945429028515
Basic UDI-DI: 69454290WS002T3
Direct Marketing DI: 06945429028515
EMDN Code: Z12020402 Light sources for endoscopy and minimally invasive surgery

Device Class: Class I
EU market of registration: Finland

Manufacturer details

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

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Properties

Other properties (13)

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
Measuring Function: No
Incorporates Medicinal Product: No