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Oz 1001101

by Berchtold Holding GmbH

Ref OZ 1001101Model 08858250000755SF

Oz 1001101 is a Class I device made by Berchtold Holding GmbH, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 08858250000755SF) and listed in FDA GUDID since 25 May 2021 (UDI-DI 07613327170207), 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 Number08858250000755SF Basic UDI-DI 07613327170207UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327170207 UDI-DI Date25 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000755SF registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 07613327170207 listed 25 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327170207
  2. Registered EUDAMED 08858250000755SF

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  • Withdrawn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
Anaesthesia screen
Device name
COM_TF10469_Anesthesia Screen
Model / Ref / Catalog
OZ 1001101, 08858250000755SF
Description
Anesthesia screen with radial setting. Keep Dry.
Primary DI / UDI-DI
07613327170207
Basic UDI-DI
08858250000755SF
Direct marketing DI
07613327170207
FDA product code
CCX
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Anaesthesia screen
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: Anaesthesia screen

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)