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Reference Plate Maj-1860

by Olympus Medical Systems Corporation

Ref N3806100

Reference Plate Maj-1860 is a device classified as Class IIa 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 495317000055BG), cleared under FDA 510(k) K103312 on 12 May 2011 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170305672), 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 Number495317000055BG Basic UDI-DI 04953170305672UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170305672 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 495317000055BG registered 23 Oct 2026 Active
  • FDA 510(k) K103312 decided 12 May 2011 Active
  • FDA GUDID UDI-DI 04953170305672 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103312
  2. Listed FDA GUDID 04953170305672
  3. Registered EUDAMED 495317000055BG

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  • Withdrawn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
Reference Plate Maj-1860 EUDAMED
Reference Plate GUDID
Generic name
Electromagnetic endoscope tracking system reference transmitter, external, body-surface
Device name
Accessory_Electromagnetic Endoscope Tracking System Reference Transmitter, External, Body-Surface
Model / reference
N3806100 EUDAMED
MAJ-1860 GUDID
Primary DI / UDI-DI
04953170305672
Basic UDI-DI
495317000055BG
FDA product code
FDF
EMDN code
Z12020680 Lower gastrointestinal tract endoscopy instruments - hardware accessories
GMDN term
Electromagnetic endoscope tracking system reference transmitter, external, body-surface
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
Sterilisation method
High-level Disinfectant

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N3806100
GUDID
MAJ-1860
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04953170305672: EUDAMED states No, FDA GUDID states Yes.

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: Electromagnetic endoscope tracking system reference transmitter, external, body-surface

Cleared under the same submission (K103312)

and 3 more cleared under K103312

Similar devices in this category

Other devices filed under LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)