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Olympus MAJ-1651

by KeyMed (Medical and Industrial Equipment) Ltd

Ref K10023086Model AUXILIARY CHANNEL WATER TUBE SET

Olympus MAJ-1651 is a device classified as Class IIa in the EU and Class II in the US made by KeyMed (Medical and Industrial Equipment) Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 5019778MF001005A3) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 15019778004716), 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 Number5019778MF001005A3 Basic UDI-DI 15019778004716UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15019778004716 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5019778MF001005A3 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 15019778004716 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15019778004716
  2. Registered EUDAMED 5019778MF001005A3

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  • Withdrawn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
Auxiliary Channel Water Tube Set Maj-1651 - PK10 EUDAMED
Olympus GUDID
Generic name
Cardiac ablation system irrigation tubing set
Model / reference
AUXILIARY CHANNEL WATER TUBE SET EUDAMED
K10023086 EUDAMED
MAJ-1651 GUDID
Primary DI / UDI-DI
15019778004716
Basic UDI-DI
5019778MF001005A3
FDA product code
FEQ
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Cardiac ablation system irrigation tubing set
Device class
Class IIa 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
AUXILIARY CHANNEL WATER TUBE SET
K10023086
GUDID
MAJ-1651
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: Cardiac ablation system irrigation tubing set

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

Other devices from KeyMed (Medical and Industrial Equipment) Ltd

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)