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STARBoard

by Adept Medical Ltd

Ref AM0100E

STARBoard (AM0100E) is a Class I device made by Adept Medical Ltd, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 942190518756AM0100E8W) and listed in FDA GUDID since 1 Jul 2022 (UDI-DI 09421905187565), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number942190518756AM0100E8W Basic UDI-DI 09421905187565UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09421905187565 UDI-DI Date1 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 942190518756AM0100E8W registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 09421905187565 listed 1 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09421905187565
  2. Registered EUDAMED 942190518756AM0100E8W

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  • Withdrawn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

Trade name
Adept Medical STARBoard and STARSupport
Generic name
Radiological arm/leg positioner
Device name
STARBoard
Model / Ref / Catalog
AM0100E EUDAMED
E GUDID
AM100E GUDID
Primary DI / UDI-DI
09421905187565
Basic UDI-DI
942190518756AM0100E8W
Direct marketing DI
09421905187565
FDA product code
CCX
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Radiological arm/leg positioner
Device class
Class I
Regulation number
868.6820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Liquid Chemical

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AM0100E
GUDID
E
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 09421905187565: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

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

Related devices

Category: Electromagnetic surgical navigation device tracking system

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

  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)