Skip to content

Aptiva System Cleaning Solution Kit

by Inova Diagnostics. Inc.

Ref AC1003

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

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0195126000871QG Basic UDI-DI 00195126000871UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00195126000871 UDI-DI Date18 Mar 2024ListedStatusListed 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  • Withdrawn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/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Instrument/analyser cleaning agent IVD
Model / Reference
AC1003
Primary DI / UDI-DI
00195126000871
Basic UDI-DI
0195126000871QG
FDA Product Code
NSU
EMDN Code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
GMDN Term
Instrument/analyser cleaning agent IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.2570
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017851
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Inova Diagnostics, Inc.

See all devices from Inova Diagnostics, Inc. →

Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No