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Barco

by Barco, Inc. 3 variants

Ref AMM215WTTPModel surgical monitor

Barco (AMM215WTTP) is an image display unit (EU MDR Class I; FDA Class I; FDA product code KQM, Camera, Surgical And Accessories) made by Barco, Inc., registered in EUDAMED on 23 Oct 2024 (Basic UDI-DI 5415334_Surgical-US_DL) and listed in FDA GUDID since 1 Mar 2022 (UDI-DI 00700621719502), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415334_Surgical-US_DL Basic UDI-DI 00700621719502UDI-DIDate23 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00700621719502 UDI-DI Date1 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5415334_Surgical-US_DL registered 23 Oct 2024 Active
  • FDA GUDID UDI-DI 00700621719502 listed 1 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00700621719502
  2. Registered EUDAMED 5415334_Surgical-US_DL

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  • Withdrawn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

Generic name
Image display unit, colour
Device name
AMM215WTTP, AMM215WTD, AMM240ED
Model / reference
surgical monitor, AMM215WTTP
Primary DI / UDI-DI
00700621719502
Basic UDI-DI
5415334_Surgical-US_DL
FDA product code
KQM
EMDN code
Z11900802 Bioimaging viewing monitors
GMDN term
Image display unit, colour
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000018743
Authorised representative
Barco NV BE-AR-000003385

Similar devices in this category

Other devices filed under BIOIMAGING VIEWING MONITORS.

Other devices from Barco, Inc.

See all devices from Barco, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)