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Aircore™ Offloading Insole

by DARCO International, Inc. 9 variants

Ref ACIP115

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number060927198970AU Basic UDI-DI 00609271989702UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00609271989702 UDI-DI Date7 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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 EUDAMED
Aircore™ Insole GUDID
Generic Name
Pressure-management insole, prefabricated
Model / Reference
ACIP115
Primary DI / UDI-DI
00609271989702
Basic UDI-DI
060927198970AU
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 market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000016195
Authorised representative
Darco (Europe) GmbH DE-AR-000010120

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 (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No