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TMS Strep A

by Dutch Diagnostics B.V. EUDAMED

Active European Union

Ref 21.019-7

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DD-STA-21019-7GV Basic UDI-DIDate23 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Strep A Test
Model / Reference
21.019-7
Primary DI / UDI-DI
D-DD-STA-21019-7GV
Basic UDI-DI
B-DD-STA-21019-7GV
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000027769

Other devices from Dutch Diagnostics B.V.

See all devices from Dutch Diagnostics B.V. →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No