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SprintRay Foundation Scanner

by Alliedstar Medical Equipment Co., Ltd.

Part of a family of 89 devices: see the family page

Ref 6583643Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1

SprintRay Foundation Scanner (6583643) is a device classified as Class I in the EU and Class II in the US made by Alliedstar Medical Equipment Co., Ltd., registered in EUDAMED on 12 Jun 2025 (Basic UDI-DI 697399344alliedstar01SL) and listed in FDA GUDID since 23 Oct 2026 (UDI-DI 06973993442758), active as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973993442758 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697399344alliedstar01SL Basic UDI-DI 06973993442758UDI-DIDate12 Jun 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697399344alliedstar01SL registered 12 Jun 2025 Active
  • FDA GUDID UDI-DI 06973993442758 listed 23 Oct 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697399344alliedstar01SL
  2. Listed FDA GUDID 06973993442758

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  • Withdrawn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
Intraoral optical scanning system
Device name
Intraoral Scanner
Model / Ref / Catalog
AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1, 6583643
Primary DI / UDI-DI
06973993442758
Basic UDI-DI
697399344alliedstar01SL
FDA product code
NOF
EMDN code
Q010207 Dental impression devices for prosthetic dentistry
GMDN term
Intraoral optical scanning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3661
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
CN-MF-000008845
Authorised representative
Etkon GmbH DE-AR-000009335

Similar devices in this category

Other devices filed under DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Alliedstar Medical Equipment Co., Ltd.

See all devices from Alliedstar Medical Equipment Co., Ltd. →

Properties

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