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Otopront Sit 4

by Happersberger Otopront GmbH

Part of a family of 6 devices: see the family page

Ref 100666Model SIT 4

Otopront Sit 4 is an ENT chair (EU MDR Class I; FDA Class I; FDA product code GBB, Chair, Surgical, Ac-Powered) made by Happersberger Otopront GmbH, registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI 426015454SITTC202111101FR) and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04260154548100), 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 Number426015454SITTC202111101FR Basic UDI-DI 04260154548100UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260154548100 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426015454SITTC202111101FR registered 16 Apr 2026 Active
  • FDA GUDID UDI-DI 04260154548100 listed 4 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260154548100
  2. Registered EUDAMED 426015454SITTC202111101FR

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  • Withdrawn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
Sit 4 EUDAMED
Otopront GUDID
Generic name
ENT chair, electric
Device name
ENT Treatment Chair
Model / reference
SIT 4, 100666
Primary DI / UDI-DI
04260154548100
Basic UDI-DI
426015454SITTC202111101FR
FDA product code
GBB
EMDN code
V08020101 Generic use electric medical chairs
GMDN term
ENT chair, electric
Device class
Class I
Regulation number
878.4960
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENT chair, electric

Similar devices in this category

Other devices filed under GENERIC USE ELECTRIC MEDICAL CHAIRS.

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)