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Mouthpiece Ma-392

by Olympus Medical Systems Corporation

Ref GX9038

Mouthpiece Ma-392 is a Class I device made by Olympus Medical Systems Corporation, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 495317000061BB) and listed in FDA GUDID since 21 Sep 2018 (UDI-DI 04953170071577), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000061BB Basic UDI-DI 04953170071577UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170071577 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 495317000061BB registered 26 Aug 2026 Active
  • FDA GUDID UDI-DI 04953170071577 listed 21 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04953170071577
  2. Registered EUDAMED 495317000061BB

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  • Withdrawn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
Mouthpiece Ma-392 EUDAMED
Mouthpiece GUDID
Generic name
Endoscopic bite block, basic, reusable
Model / reference
GX9038 EUDAMED
MA-392 GUDID
Primary DI / UDI-DI
04953170071577
Basic UDI-DI
495317000061BB
FDA product code
MNK
EMDN code
G0399 Digestive endoscopy devices - other
GMDN term
Endoscopic bite block, basic, reusable
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
GX9038
GUDID
MA-392

Related devices

Category: Endoscopic bite block, basic, reusable

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - OTHER.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)