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ENNOLIFE Screen Panel

by ProtectLife International Biomedical Inc. EUDAMED

Active European Union

Ref 001-3D2AModel HCA-TE-300

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G322G3220013D2A18PZ 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  • Withdrawn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, 001-3D2A
Primary DI / UDI-DI
++G3220013D2A
Basic UDI-DI
++G322G3220013D2A18PZ
EMDN Code
W0101060109 Multiple parameter blood test
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.

See all devices from ProtectLife International Biomedical Inc. →

Properties

Show 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