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Rigid Endoscope otopront 30°

by Happersberger otopront GmbH Greece EUDAMEDGUDID

Ref 325175

Product code ERAEMDN Z12021099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260154547479 UDI-DIDate8 Jul 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number426015454RIGEN202121203TC Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Rigid Endoscope otopront 30° EUDAMED
Otopront GUDID
Generic Name
Otoscope, endoscopic
Device Name
Rigid Endoscope
Model / Reference
325175 EUDAMED
Rigid Endoscope otopront 30° GUDID
Primary DI / UDI-DI
04260154547479
Basic UDI-DI
426015454RIGEN202121203TC
FDA Product Code
ERA
EMDN Code
Z12021099 ENT endoscopy instruments - other
GMDN Term
Otoscope, endoscopic
Device Class
Class I
Regulation Number
874.4770
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
325175
GUDID
Rigid Endoscope otopront 30°

Manufacturer details

EUDAMED SRN
DE-MF-000017407

Other devices from Happersberger Otopront GmbH

See all devices from Happersberger Otopront GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Premarket Exempt
  • Serial Number
Other properties (21)
  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED fa055c50-6914-4583-b589-abcba1460d69 61 fields · synced 23 Oct 2026
  • FDA UDI f285da42-6b87-42da-8930-f4c640ef071f 32 fields · synced 23 Oct 2026