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ENNOLIFE HbA1c Disc

by ProtectLife International Biomedical Inc. Taiwan EUDAMED

Ref 001-218BModel HCA-TE-300 EMDN W0103010699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G322G322001218BL8MB 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)
Model / Reference
HCA-TE-300, 001-218B
Primary DI / UDI-DI
++G322001218B
Basic UDI-DI
++G322G322001218BL8MB
EMDN Code
W0103010699 Haematology rapid tests & point of care - other
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 & 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 ce8a550a-3c27-4ef6-be56-b4f24514a8e3 61 fields · synced 22 Oct 2026