Skip to content

EASYMAX® Glucose Control Solution

by EPS Bio Technology Corp. 3 variants

Ref 680.06Model P-01

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471394568CP01DJ Basic UDI-DI 04713945680065UDI-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  • Withdrawn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
P-01, 680.06
Primary DI / UDI-DI
04713945680065
Basic UDI-DI
471394568CP01DJ
Direct Marketing DI
04713945680065
EMDN Code
W010106010801 Blood test strips controls
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.

See all devices from Eps Bio Technology Corp. →

Properties

  • Reagent
  • Self Testing

Other properties (9)

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