Skip to content

Medit Splints

by Medit Corp.

Ref MA-ASP

Medit Splints is a CAD/CAM software (EU MDR Class IIa; FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 88000267MA-ASPA8) and listed in FDA GUDID since 2 Aug 2023 (UDI-DI 08800026700173), active as of 8 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 8 Oct 2026.

Regulatory status

as of registry sync 8 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000267MA-ASPA8 Basic UDI-DI 08800026700173UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026700173 UDI-DI Date2 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MA-ASPA8 registered 26 May 2026 Active
  • FDA GUDID UDI-DI 08800026700173 listed 2 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800026700173
  2. Registered EUDAMED 88000267MA-ASPA8

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  • Withdrawn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
CAD/CAM software
Model / reference
MA-ASP EUDAMED
Medit Splints GUDID
Primary DI / UDI-DI
08800026700173
Basic UDI-DI
88000267MA-ASPA8
Direct marketing DI
08800026700173
FDA product code
NOF
EMDN code
Z12119082 Various dental stomatology instruments - software accessories
GMDN term
CAD/CAM software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3661
Special device type
Software
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
MA-ASP
GUDID
Medit Splints
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: CAD/CAM software

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS.

Other devices from Medit Corp.

See all devices from Medit Corp. →

Properties

  • Premarket exempt
Other properties (24, all answered No)