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Olympus MAJ-1603

by KeyMed (Medical and Industrial Equipment) Ltd

Ref K10007071Model WATER CONTAINER

Olympus MAJ-1603 (K10007071) is a device classified as Class I in the EU and Class II in the US made by KeyMed (Medical and Industrial Equipment) Ltd, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 5019778MF0010019T) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 15019778003344), 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 Number5019778MF0010019T Basic UDI-DI 15019778003344UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15019778003344 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5019778MF0010019T registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 15019778003344 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15019778003344
  2. Registered EUDAMED 5019778MF0010019T

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  • Withdrawn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
Maj-1603 Water Container - 2l - PK3 EUDAMED
Olympus GUDID
Generic name
Endoscopic irrigation/distension bottle
Model / Ref / Catalog
WATER CONTAINER, K10007071, MAJ-1603
Primary DI / UDI-DI
15019778003344
Basic UDI-DI
5019778MF0010019T
FDA product code
FEQ
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Endoscopic irrigation/distension bottle
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
WATER CONTAINER
K10007071
GUDID
MAJ-1603
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: Endoscopic irrigation/aspiration pump

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

Other devices from KeyMed (Medical and Industrial Equipment) Ltd

See all devices from KeyMed (Medical and Industrial Equipment) Ltd →

Properties

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