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STARBoard Extension

by Adept Medical Ltd

Ref AM0190

STARBoard Extension (AM0190) is a Class I device made by Adept Medical Ltd, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 9421902825AM0190V3) and listed in FDA GUDID since 24 Nov 2017 (UDI-DI 09421902825897), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9421902825AM0190V3 Basic UDI-DI 09421902825897UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09421902825897 UDI-DI Date24 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 9421902825AM0190V3 registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 09421902825897 listed 24 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09421902825897
  2. Registered EUDAMED 9421902825AM0190V3

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  • Withdrawn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
Instrument table
Model / Ref / Catalog
AM0190
Primary DI / UDI-DI
09421902825897
Basic UDI-DI
9421902825AM0190V3
FDA product code
FWZ
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Instrument table
Device class
Class I
Regulation number
878.4950
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
NZ-MF-000003374
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER.

Other devices from Adept Medical Ltd

See all devices from Adept Medical Ltd →

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (22, all answered No)