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ENNOLIFE TC/TG/GLU Panel

by ProtectLife International Biomedical Inc. EUDAMED

Active European Union

Ref 001-236CModel HCA-TE-300

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G322G322001236CLENG Basic UDI-DIDate28 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)
Model / Reference
HCA-TE-300, 001-236C
Primary DI / UDI-DI
++G322001236C
Basic UDI-DI
++G322G322001236CLENG
EMDN Code
W01010205,W01010213,W01010231
Device Class
Class C
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
TW-MF-000039217
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from ProtectLife International Biomedical Inc.

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Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (8)

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