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Olympus MAJ-1607

by KeyMed (Medical and Industrial Equipment) Ltd

Ref K10016136Model INSTRUMENT CHANNEL WATER TUBE

Olympus MAJ-1607 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 29 Oct 2026 (Basic UDI-DI 5019778MF0010039X) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 15019778003535), 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 Number5019778MF0010039X Basic UDI-DI 15019778003535UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15019778003535 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5019778MF0010039X registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 15019778003535 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15019778003535
  2. Registered EUDAMED 5019778MF0010039X

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  • Withdrawn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
Instrument Channel Water Tube Maj-1607 - PK10 EUDAMED
Olympus GUDID
Generic name
Cardiac ablation system irrigation tubing set
Model / reference
INSTRUMENT CHANNEL WATER TUBE EUDAMED
K10016136 EUDAMED
MAJ-1607 GUDID
Primary DI / UDI-DI
15019778003535
Basic UDI-DI
5019778MF0010039X
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
INSTRUMENT CHANNEL WATER TUBE
K10016136
GUDID
MAJ-1607
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)