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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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SPOT-it TREC, KREC & SMN1 Screening Kit — 1 UDI-DI variant, IVDD

MD Atlas
ImmunoIVD AB

Data from EUDAMED, last updated May 30, 2026

SPOT-it TREC, KREC & SMN1 Screening Kit

B-47350134361791

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: ImmunoIVD AB

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: B-47350134361791
Device name: SPOT-it TREC, KREC & SMN1 Screening Kit
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: Nov 14, 2024

Manufacturer & authorised representative

Manufacturer

Name: ImmunoIVD AB
SRN: SE-MF-000034517
Country: Sweden
Email: info@immunoivd.com
Phone: +46 840 88 98 00

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01JCN1V2TVQZG6K6PF5V4EWKGT

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

SPOT-it TREC, KREC & SMN1 Screening Kit47350134361791