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Probe/Irrigation Plug Md-807

by Olympus Medical Systems Corporation

Ref N5385930

Probe/Irrigation Plug Md-807 (N5385930) is a device classified as Class IIa in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-04953170368424) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170368424), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170368424 Basic UDI-DI 04953170368424UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170368424 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04953170368424 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 04953170368424 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04953170368424
  2. Registered EUDAMED B-04953170368424

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Probe/Irrigation Plug MD-807 EUDAMED
Probe/Irrigation Plug GUDID
Generic name
Endoscope air/water valve, reusable
Model / Ref / Catalog
N5385930, MD-807
Primary DI / UDI-DI
04953170368424
Basic UDI-DI
B-04953170368424
FDA product code
ITX, IYN, IYO, ODG, FET
EMDN code
Z1104018099 Ultrasound scanners – hardware accessories – other
GMDN term
Endoscope air/water valve, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1550, 892.1560, 876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N5385930
GUDID
MD-807
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 air/water valve, reusable

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER.

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)