Skip to content

CERA-CHEK™ Lactate Measuring System

by GC MEDIS Corp. South Korea EUDAMED

Ref L400M10Model L 400 EMDN W02010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800065158201 Basic UDI-DIDate9 Feb 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Lactate Measuring System
Model / Reference
L 400, L400M10
Primary DI / UDI-DI
08800065158201
Basic UDI-DI
B-08800065158201
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class IVD devices for self-testing
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000012638
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from GC MEDIS Corp.

See all devices from GC MEDIS Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 9573d4cb-c814-4e01-99e9-ece9422a92ed 61 fields · synced 22 Oct 2026