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Urine Analyzer

by Acro Biotech Inc. EUDAMED

Active European Union

Ref AUR-ACO200

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0810047980005AGH Basic UDI-DIDate13 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
AUR-ACO200
Primary DI / UDI-DI
00810047983873
Basic UDI-DI
0810047980005AGH
EMDN Code
W02010701 Urinalysis (ur) - laboratory analysers- instruments
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000017832
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from ACRO BIOTECH Inc.

See all devices from ACRO BIOTECH Inc. →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No