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Rigid Endoscope otopront 70°

by Happersberger otopront GmbH 3 variants

Ref 325163

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260154547486 UDI-DI Date8 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number426015454RIGEN202121203TC Basic UDI-DI 04260154547486UDI-DIDate8 May 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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Rigid Endoscope otopront 70° EUDAMED
Otopront GUDID
Generic Name
Otoscope, endoscopic
Device Name
Rigid Endoscope
Model / Reference
325163 EUDAMED
Rigid Endoscope otopront 70° GUDID
Primary DI / UDI-DI
04260154547486
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
325163
GUDID
Rigid Endoscope otopront 70°

Manufacturer details

EUDAMED SRN
DE-MF-000017407

Other devices from Happersberger Otopront GmbH

See all devices from Happersberger Otopront GmbH →

Properties

  • 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