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Eclipse PLUS

by Apex Biotechnology Corp. 3 variants

Ref S5641014 S5641015

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-47136487608BACRT2W Basic UDI-DI D-47136487608BACRT2WUDI-DIDate25 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
Eclipse PLUS ACR Reagent Kit
Model / Reference
S5641014 S5641015
Primary DI / UDI-DI
D-47136487608BACRT2W
Basic UDI-DI
B-47136487608BACRT2W
EMDN Code
W0101060201 Urine single test strips (incl. tablets)
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
TW-MF-000019773
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Apex Biotechnology Corp.

See all devices from Apex Biotechnology Corp. →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No