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EASYMAX® Blood Glucose Test Strip

by EPS Bio Technology Corp. 3 variants

Ref 680.03Model P1

Active European Union

CE IVDR

Valid until

7 Jul 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471394568TP1NK Basic UDI-DI 04713945680034UDI-DIDate10 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
P1, 680.03
Primary DI / UDI-DI
04713945680034
Basic UDI-DI
471394568TP1NK
Direct Marketing DI
04713945680034
EMDN Code
W0101060101 Glucose test strips
Device Class
Class C
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000028384
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Eps Bio Technology Corp.

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Properties

  • Microbial Substances
  • Reagent
  • Self Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No