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Water-resistant cap MH-553

by Olympus Medical Systems Corporation EUDAMEDGUDID

Active European Union

Ref N3627400

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000064BH Basic UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170286438 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Water-Resistant Cap Mh-553 EUDAMED
Water-resistant cap GUDID
Generic Name
Luminal device flushing tubing set, reusable
Device Name
Accessory_Gastrointestinal Devices - Other
Model / Ref / Catalog
N3627400, MH-553
Primary DI / UDI-DI
04953170286438
Basic UDI-DI
495317000064BH
FDA Product Code
FET
EMDN Code
G99 Gastrointestinal devices - other
GMDN Term
Luminal device flushing tubing set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N3627400
GUDID
MH-553
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Luminal device flushing tubing set, reusable

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 (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No