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Aircore™ Offloading Insole ACI1

by DARCO International, Inc.

Ref ACI1

Aircore™ Offloading Insole ACI1 is a Class I device made by DARCO International, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 060927199934AX) and listed in FDA GUDID since 20 Jul 2026 (UDI-DI 00609271999343), active as of 7 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number060927199934AX Basic UDI-DI 00609271999343UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00609271999343 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 060927199934AX registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00609271999343 listed 20 Jul 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00609271999343
  2. Registered EUDAMED 060927199934AX

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  • Withdrawn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
Aircore™ Offloading Insole
Generic name
Pressure-management insole, prefabricated
Model / reference
ACI1
Primary DI / UDI-DI
00609271999343
Basic UDI-DI
060927199934AX
FDA product code
FMP
EMDN code
Y061203 Orthoses, foot (including insoles and inserts)
GMDN term
Pressure-management insole, prefabricated
Device class
Class I
Regulation number
880.6450
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS).

Other devices from DARCO International, Inc.

See all devices from DARCO International, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)