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Connection Unit Maj-1928

by Olympus Medical Systems Corporation

Ref N3807200

Connection Unit Maj-1928 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 495317000181BN), cleared under FDA 510(k) K103312 on 12 May 2011 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170305795), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103312

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000181BN Basic UDI-DI 04953170305795UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170305795 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103312 Date12 May 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000181BN registered 23 Oct 2026 Active
  • FDA 510(k) K103312 decided 12 May 2011 Active
  • FDA GUDID UDI-DI 04953170305795 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103312
  2. Listed FDA GUDID 04953170305795
  3. Registered EUDAMED 495317000181BN

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Connection Unit Maj-1928 EUDAMED
Connection Unit GUDID
Generic name
Gastrointestinal catheter/endoscope tracking system
Device name
Gastrointestinal Catheter/Endoscope Tracking System
Model / reference
N3807200 EUDAMED
MAJ-1928 GUDID
Primary DI / UDI-DI
04953170305795
Basic UDI-DI
495317000181BN
FDA product code
FDF
EMDN code
Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories
GMDN term
Gastrointestinal catheter/endoscope tracking system
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
N3807200
GUDID
MAJ-1928
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: Gastrointestinal catheter/endoscope tracking system

Cleared under the same submission (K103312)

and 3 more cleared under K103312

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
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)