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2.5V Mini Fiber Optic Otoscope

by Rewise Tech 2 variants

Ref RT009017

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 Number8964005369RT009017TC Basic UDI-DI 08964005369017UDI-DIDate23 Sep 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  • Withdrawn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
Mini Fiber Optic Otoscope Blue Color Packed in Parachute Packing pouch with 1 LED
Model / Reference
RT009017
Primary DI / UDI-DI
08964005369017
Basic UDI-DI
8964005369RT009017TC
EMDN Code
Z12021007 Middle ear otoscopes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PK-MF-000058477
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

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See all devices from Rewise Tech →

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