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SPOT-it TREC, KREC & SMN1 Screening Kit

by ImmunoIVD AB 2 variants

Ref 4-2020-TKS

Active European Union

CE IVDR CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-37350134361794 Basic UDI-DI 37350134361794UDI-DIDate1 Mar 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-37350134361794 Basic UDI-DI 37350134361794UDI-DIDate1 Mar 2024RegisteredStatusActive

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  • Withdrawn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/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
4-2020-TKS
Primary DI / UDI-DI
37350134361794
Basic UDI-DI
B-37350134361794, 7350134361799E
Direct Marketing DI
37350134361794
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
Class C
EU market of registration
Italy
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000034517

From the manufacturer

Manufacturer's product page: SPOT-itTM TREC, KREC & SMN1 Screening Kit Screening Solution for SCID, XLA, SMA

Other devices from ImmunoIVD AB

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No