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Oz 1705675

by Berchtold Holding GmbH

Ref OZ 1705675Model 08858250000763SE

Oz 1705675 is a Class I device made by Berchtold Holding GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08858250000763SE) and listed in FDA GUDID since 25 May 2021 (UDI-DI 07613327459548), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000763SE Basic UDI-DI 07613327459548UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327459548 UDI-DI Date25 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000763SE registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 07613327459548 listed 25 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327459548
  2. Registered EUDAMED 08858250000763SE

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  • Withdrawn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

Generic name
Urological operating table top
Device name
COM_TF10469_TUR Module
Model / Ref / Catalog
OZ 1705675, 08858250000763SE
Description
TUR module for Operon D 850, US. Keep Dry.
Primary DI / UDI-DI
07613327459548
Basic UDI-DI
08858250000763SE
Direct marketing DI
07613327459548
FDA product code
CCX
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Urological operating table top
Device class
Class I
Regulation number
868.6820
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Urological operating table top

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Berchtold Holding GmbH

See all devices from Berchtold Holding GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)