Headlight with Binocular Loupes

by Zumax Medical CO., LTD. 101 variants

Ref 578-3550

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 linked in EUDAMED

A group certificate may exist

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	Number69450955headlight7K Basic UDI-DI 06945095546221UDI-DI	Date7 May 2026Registered	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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Headlight
Headlight with Binocular Loupe
Model / Reference: 578-3550

Primary DI / UDI-DI: 06945095546221
Basic UDI-DI: 69450955headlight7K, 69450955headlightloupes6E
EMDN Code: Z12010702, Q0299

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000011126
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zumax Medical Co., LTD

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Class I
Headlight with Binocular Loupes

Class I
22-1025

Class I
OMS3500

Class I
OMS2650

Class I
OMS3200

Class I

See all devices from Zumax Medical Co., LTD →

Properties

Reusable

Other properties (12)

Sterile: No
Implantable: 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