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Suction valve MH-443

by Olympus Medical Systems Corporation

Ref GV394900

Suction valve MH-443 is a device classified as Class I in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 495317000039BJ) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170071256), 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 Number495317000039BJ Basic UDI-DI 04953170071256UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170071256 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 495317000039BJ registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 04953170071256 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04953170071256
  2. Registered EUDAMED 495317000039BJ

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  • Withdrawn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
Suction Valve Mh-443 EUDAMED
Suction valve GUDID
Generic name
Endoscope suction valve, reusable
Model / reference
GV394900 EUDAMED
MH-443 GUDID
Primary DI / UDI-DI
04953170071256
Basic UDI-DI
495317000039BJ
FDA product code
FDS, NWB, FDF
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Endoscope suction valve, reusable
Device class
Class I EUDAMED
Class II GUDID
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GV394900
GUDID
MH-443
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscope suction valve, reusable

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)