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Collection Kit 14

by Remi Health GmbH

Ref P-Box-A-Var14-5x1173

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42624479006NW Basic UDI-DI 04262447940622UDI-DIDate31 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  • Withdrawn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 + Speichel - Probenahme, Aufbewahrungs und Einsende Kit
Model / Reference
P-Box-A-Var14-5x1173
Primary DI / UDI-DI
04262447940622
Basic UDI-DI
42624479006NW
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class IIa
Medical Purpose
Dieses Kit dient der Entnahme von Speichel- und Kapillarblutproben durch Laienanwender:innen in häuslicher Umgebung, der primären Aufbewahrung, Erhaltung sowie dem Probenversand in ein Kooperationslabor. Die Analyse und Bewertung erfolgen ausschließlich im Labor; das Kit selbst stellt keine Diagnose.

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