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MyHealthChecked

by Concepta Diagnostics EUDAMED

Active European Union

Ref P4000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075735P4000XG Basic UDI-DIDate25 Apr 2025RegisteredStatusActive

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  • Withdrawn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 Phlebotomy Sample Collection Kit (butterfly needle) – Gold Tube (Single Test)
Model / Reference
P4000
Primary DI / UDI-DI
05060757350839
Basic UDI-DI
506075735P4000XG
EMDN Code
W0501010199 Venous or arterious blood collection devices - other
Device Class
Class IIa
Medical Purpose
The MyHealthChecked Phlebotomy Blood Sample Collection Kit (butterfly needle) – Gold Tube is for use by trained phlebotomists to collect and package venous blood specimens for transport to our laboratory to analyse for a variety of tests that involve human blood. The complete Intended Use is contained in the Information Card package insert.

Manufacturer details

EUDAMED SRN
GB-PR-000033063

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Properties

  • Sterile