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ENT ENDOSCOPY INSTRUMENTS(Otoscope)

by Zhejiang Tiansong Medical Instrument Co., Ltd 18 variants

Ref C0010AModel /

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69450142Z120210073E Basic UDI-DI 06945014218543UDI-DIDate3 Jun 2026RegisteredStatusActive

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

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ENT ENDOSCOPY INSTRUMENTS(Otoscope)
Model / Reference
/, C0010A
Primary DI / UDI-DI
06945014218543
Basic UDI-DI
69450142Z120210073E
EMDN Code
Z12021007 Middle ear otoscopes
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000008834
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang Tiansong Medical Instrument Co., Ltd

See all devices from Zhejiang Tiansong Medical Instrument 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