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MyHealthChecked

by Concepta Diagnostics EUDAMED

Active European Union

Ref B5000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075735B5000SV Basic UDI-DIDate3 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
MyHealthChecked Blood Sample Collection Kit – Gold Tube (Home Use – Single Test)
Model / Reference
B5000
Primary DI / UDI-DI
05060757350051
Basic UDI-DI
506075735B5000SV
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class I
Medical Purpose
Blood Sample Collection Kit – Gold Tube (Home Use – Single Test) Thyroid Profile Blood Sample Collection Kit (Home Use – Single Test) Vitamins & Minerals Profile Blood Sample Collection Kit (Home Use – Single Test) Menopause Profile Blood Sample Collection Kit (Home Use – Single Test) Polycystic Ovary Syndrome (PCOS) Blood Sample Collection Kit (Home Use – Single Test) Female Fertility Blood Sample Collection Kit (Home Use – Single Test) Progesterone Blood Sample Collection Kit (Home Use – Single Test)

Manufacturer details

EUDAMED SRN
GB-PR-000033063

Other devices from Concepta Diagnostics

See all devices from Concepta Diagnostics →

Properties

  • Sterile