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AiD Regen

by ROKIT HEALTHCARE Inc.

Ref AIDR-001

AiD Regen (AIDR-001) is a CAD/CAM software (EU MDR Class I; FDA Class I; FDA product code OUG, Medical Device Data System) made by Rokit Healthcare Inc., registered in EUDAMED on 10 Apr 2025 (Basic UDI-DI 880969250AIDR001P5) and listed in FDA GUDID since 14 Nov 2024 (UDI-DI 08809692507000), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880969250AIDR001P5 Basic UDI-DI 08809692507000UDI-DIDate10 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08809692507000 UDI-DI Date14 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880969250AIDR001P5 registered 10 Apr 2025 Active
  • FDA GUDID UDI-DI 08809692507000 listed 14 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809692507000
  2. Registered EUDAMED 880969250AIDR001P5

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  • Withdrawn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
AIDR-001
Primary DI / UDI-DI
08809692507000
Basic UDI-DI
880969250AIDR001P5
Direct marketing DI
08809692507000
FDA product code
OUG
EMDN code
V92 Medical device software - not included in other classes
GMDN term
CAD/CAM software
Device class
Class I
Regulation number
880.6310
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000009720
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Rokit Healthcare Inc.

Properties

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