Skip to content

MIRATECH Luteinizing Hormone Tests for self-testing

by Artron Laboratories Inc.

Ref A01-03-130MT5

Active European Union

CE IVDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00628347568290 Basic UDI-DI 00628347568290UDI-DIDate16 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
LH Midstream
Model / Reference
A01-03-130MT5
Primary DI / UDI-DI
00628347568290
Basic UDI-DI
B-00628347568290
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CA-MF-000028974
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

From the manufacturer

Manufacturer's product page: How a Canadian manufacturer of COVID rapid tests is working to meet the crushing demand – By CityNews Everywhere

Other devices from Artron Laboratories Inc.

See all devices from Artron Laboratories Inc. →

Properties

  • Reagent
  • Self Testing

Other properties (9)

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