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Medical Endoscopic Fluorescence Cold Light Source

by Weyo Surgical Technology Ltd. 6 variants

Ref wMizar F10uModel wMizar F10u, wMizar F10p, wMizar F10g, wMizar F10s, wMizar F10e, wMizar F10b

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697562167Z12020402028E Basic UDI-DI 06975621670519UDI-DIDate12 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical Endoscopic Fluorescence Cold Light Source
Model / Reference
wMizar F10u, wMizar F10p, wMizar F10g, wMizar F10s, wMizar F10e, wMizar F10b, wMizar F10u
Primary DI / UDI-DI
06975621670519
Basic UDI-DI
697562167Z12020402028E
EMDN Code
Z12020402 Light sources for endoscopy and minimally invasive surgery
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000038773
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Weyo Surgical Technology Ltd.

See all devices from Weyo Surgical Technology Ltd. →

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