Skip to content

OTOPRONT SIT MAX one

by Happersberger Otopront GmbH

Ref 101200Model SIT MAX one

OTOPRONT SIT MAX one 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 426015454SITMO202411102M5) and listed in FDA GUDID since 2 Dec 2024 (UDI-DI 04260154540258), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426015454SITMO202411102M5 Basic UDI-DI 04260154540258UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260154540258 UDI-DI Date2 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426015454SITMO202411102M5 registered 16 Apr 2026 Active
  • FDA GUDID UDI-DI 04260154540258 listed 2 Dec 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260154540258
  2. Registered EUDAMED 426015454SITMO202411102M5

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  • Withdrawn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 MAX one EUDAMED
Otopront GUDID
Generic name
ENT chair, electric
Device name
Examination Chair
Model / reference
SIT MAX one, 101200
Primary DI / UDI-DI
04260154540258
Basic UDI-DI
426015454SITMO202411102M5
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)