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OTOPRONT PES Pilot HDpro

by Happersberger Otopront GmbH

Ref 350035Model PES Pilot HDpro

OTOPRONT PES Pilot HDpro is a Class I device made by Happersberger Otopront GmbH, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 426015454PESPL202121101A3) and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04260154546663), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426015454PESPL202121101A3 Basic UDI-DI 04260154546663UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260154546663 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426015454PESPL202121101A3 registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 04260154546663 listed 4 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260154546663
  2. Registered EUDAMED 426015454PESPL202121101A3

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  • Withdrawn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
PES Pilot HDpro EUDAMED
Otopront GUDID
Generic name
Endoscope video camera
Device name
Portable Endoscopy System
Model / reference
PES Pilot HDpro, 350035
Primary DI / UDI-DI
04260154546663
Basic UDI-DI
426015454PESPL202121101A3
FDA product code
FWC
EMDN code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
GMDN term
Endoscope video camera
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope video camera

Similar devices in this category

Other devices filed under INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES.

Other devices from Happersberger Otopront GmbH

See all devices from Happersberger Otopront GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)