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SPOT-it TREC & SMN1 Screening Kit

by ImmunoIVD AB 2 variants

Ref 12-2020-TS

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/IVDD Number7350134361789C Basic UDI-DI 47350134361784UDI-DIDate17 Feb 2025RegisteredStatusActive
European UnionCE/IVDR Number7350134361789C Basic UDI-DI 47350134361784UDI-DIDate17 Feb 2025RegisteredStatusActive

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  • Withdrawn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/IVDD, CE/IVDR Active

Specification

EUDAMED

Model / Reference
12-2020-TS
Primary DI / UDI-DI
47350134361784
Basic UDI-DI
7350134361789C, B-47350134361784
Direct Marketing DI
47350134361784
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class C
Class IVD General
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000034517

From the manufacturer

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

Other devices from ImmunoIVD AB

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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