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STI Standard 5

by Remi Health GmbH

Ref STI Standard 5

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 Number4270003406703P2 Basic UDI-DI 42700034067036UDI-DIDate14 Jan 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  • Withdrawn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

Model / Reference
STI Standard 5
Primary DI / UDI-DI
42700034067036
Basic UDI-DI
4270003406703P2
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class IIa
Medical Purpose
Sexual Health/STI Home Testing Kit

Manufacturer details

EUDAMED SRN
DE-PR-000043145

Other devices from Remi Health GmbH

See all devices from Remi Health GmbH →

Properties

  • Sterile