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White cap MH-155

by Olympus Medical Systems Corporation

Ref 3769400

White cap MH-155 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 23 Oct 2026 (Basic UDI-DI 495317000160BE) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170027147), 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 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/MDR EUDAMED Number495317000160BE Basic UDI-DI 04953170027147UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170027147 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 495317000160BE registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 04953170027147 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04953170027147
  2. Registered EUDAMED 495317000160BE

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  • Withdrawn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
White Cap Mh-155 EUDAMED
White cap GUDID
Generic name
Endoscope calibration cover, reusable
Model / reference
3769400 EUDAMED
MH-155 GUDID
Primary DI / UDI-DI
04953170027147
Basic UDI-DI
495317000160BE
FDA product code
FDF, FDS, NWB
EMDN code
Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories
GMDN term
Endoscope calibration cover, 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
3769400
GUDID
MH-155
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 calibration cover, reusable

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)