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Collection Kit 10

by Remi Health GmbH

Ref P-Box-A-Var8-5x1169

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42624479001NL Basic UDI-DI 04262447940561UDI-DIDate10 Aug 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Blut / Kapillar - Probenahme, Aufbewahrungs und Einsende Kit
Model / Reference
P-Box-A-Var8-5x1169
Primary DI / UDI-DI
04262447940561
Basic UDI-DI
42624479001NL
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class IIa
Medical Purpose
Diese Behandlungseinheit dient der Entnahme einer Kapillarblutprobe durch Laienanwender:innen in der häuslichen Umgebung, der primären Aufbewahrung, Erhaltung sowie dem Probenversand in ein Kooperationslabor.

Manufacturer details

EUDAMED SRN
DE-PR-000043145

Other devices from Remi Health GmbH

See all devices from Remi Health GmbH →

Properties

Other properties (1)

  • Sterile: No