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ENNOLIFE HDL Cholesterol Kit (Non-sterile)

by ProtectLife International Biomedical Inc.

Ref 001-218AModel HCA-TE-300

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G322G322001218A11JA Basic UDI-DI ++G322001218AUDI-DIDate28 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)
Model / Reference
HCA-TE-300, 001-218A
Primary DI / UDI-DI
++G322001218A
Basic UDI-DI
++G322G322001218A11JA
EMDN Code
W01010205 Cholesterol
Device Class
Class B
EU market of registration
Romania

Manufacturer details

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

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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