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ENNOLIFE ACR & UPCR Test for Urinalysis (Non-sterile)

by ProtectLife International Biomedical Inc. Taiwan EUDAMED

Ref 001-256DModel HCA-TE-300

EMDN W010106020302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G322G322001256D16KZ Basic UDI-DIDate28 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)
Model / Reference
HCA-TE-300, 001-256D
Primary DI / UDI-DI
++G322001256D
Basic UDI-DI
++G322G322001256D16KZ
EMDN Code
W010106020302 Urine sediment test kit (automated)
Device Class
Class B
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED d81d3a36-6772-4d59-9ba2-9be4f53e63ff 61 fields · synced 22 Oct 2026