Skip to content

Heltes

by Artron Laboratories Inc. 5 variants

Ref A01-06-422HT1Model Cassette

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00628347568214 Basic UDI-DI 00628347568214UDI-DIDate26 May 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  • Withdrawn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
Male Fertility Sperm Tests for Self-testing
Model / Reference
Cassette, A01-06-422HT1
Primary DI / UDI-DI
00628347568214
Basic UDI-DI
B-00628347568214
EMDN Code
W0102160399 Fertility/pregnancy rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Poland

Manufacturer details

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

Other devices from Artron Laboratories Inc.

See all devices from Artron Laboratories Inc. →

Properties

  • Self Testing

Other properties (9)

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