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Attachment for Uwit Maj-2011

by Olympus Medical Systems Corporation

Ref N4471100

Attachment for Uwit Maj-2011 is a portable active medical device mount (EU MDR Class I; FDA Class II; FDA product code GCJ, Laparoscope, general & plastic surgery) made by Olympus Medical Systems Corporation, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 495317000156BP), cleared under FDA 510(k) K120278 on 10 Aug 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170327735), 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) K120278

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 Number495317000156BP Basic UDI-DI 04953170327735UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170327735 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120278 Date10 Aug 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000156BP registered 23 Oct 2026 Active
  • FDA 510(k) K120278 decided 10 Aug 2012 Active
  • FDA GUDID UDI-DI 04953170327735 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120278
  2. Listed FDA GUDID 04953170327735
  3. Registered EUDAMED 495317000156BP

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  • Withdrawn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
Attachment for Uwit Maj-2011 EUDAMED
Attachment for Uwit GUDID
Generic name
Portable active medical device mount
Device name
Accessory_Portable Active Medical Device Mount
Model / reference
N4471100 EUDAMED
MAJ-2011 GUDID
Primary DI / UDI-DI
04953170327735
Basic UDI-DI
495317000156BP
510(k) Number
FDA product code
GCJ
EMDN code
Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories
GMDN term
Portable active medical device mount
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
N4471100
GUDID
MAJ-2011
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: Portable active medical device mount

Cleared under the same submission (K120278)

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
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)