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Flexible Videoscopes

by Zhejiang UE Medical Corp. 29 variants

Ref PL-F520Model TIC-I0,TIC-I1,TIC-I2,TIC-I3,TIC-I4,TIC-I5,PL-F260,PL-F320,PL-F400,PL-F520,PL-SF280,PL-SF380,PL-SF420,PL-SF480,PL-SF520

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697028348UE000019JJ Basic UDI-DI 06937048209413UDI-DIDate7 Mar 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  • Withdrawn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

Model / Reference
TIC-I0, TIC-I1, TIC-I2, TIC-I3, TIC-I4, TIC-I5, PL-F260, PL-F320, PL-F400, PL-F520, PL-SF280, PL-SF380, PL-SF420, PL-SF480, PL-SF520
Primary DI / UDI-DI
06937048209413
Basic UDI-DI
697028348UE000019JJ
EMDN Code
Z12021006 Video nasopharyngo/laryngoscopes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000003020
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang UE Medical Corp.

See all devices from Zhejiang UE Medical Corp. →

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