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Olympus MAJ-1632

by KeyMed (Medical and Industrial Equipment) Ltd

Ref K10020960Model ENDOSCOPE MOUTHPIECE - LIP PRESS

Olympus MAJ-1632 is a Class I device made by KeyMed (Medical and Industrial Equipment) Ltd, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 5019778MF005R6) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 15019778003603), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5019778MF005R6 Basic UDI-DI 15019778003603UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15019778003603 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5019778MF005R6 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 15019778003603 listed 19 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 15019778003603
  2. Registered EUDAMED 5019778MF005R6

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  • Withdrawn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
Endoscope Mouthpiece - Lip Press Maj-1632 - 50PK EUDAMED
Olympus GUDID
Generic name
Intubation teeth protector
Model / reference
ENDOSCOPE MOUTHPIECE - LIP PRESS EUDAMED
K10020960 EUDAMED
MAJ-1632 GUDID
Primary DI / UDI-DI
15019778003603
Basic UDI-DI
5019778MF005R6
FDA product code
MNK
EMDN code
G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
GMDN term
Intubation teeth protector
Device class
Class I
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ENDOSCOPE MOUTHPIECE - LIP PRESS
K10020960
GUDID
MAJ-1632

Related devices

Category: Intubation teeth protector

Similar devices in this category

Other devices filed under GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS.

Other devices from KeyMed (Medical and Industrial Equipment) Ltd

See all devices from KeyMed (Medical and Industrial Equipment) Ltd →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)