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Amplicon Suite

by SmartSeq s.r.l. Italy EUDAMED

Ref Amplicon Suite

EMDN W02079092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MF000042241L2 Basic UDI-DIDate23 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Amplicon Suite
Primary DI / UDI-DI
D-MF000042241L2
Basic UDI-DI
B-MF000042241L2
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000042241

Other devices from SmartSeq s.r.l.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED acaccd33-08b1-45cd-a415-549515a3aff9 61 fields · synced 22 Oct 2026