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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 & SMN1 Screening Kit — 2 UDI-DI variants, IVDR

MD Atlas
ImmunoIVD AB

Data from EUDAMED, last updated May 31, 2026

SPOT-it TREC & SMN1 Screening Kit

7350134361789C

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class C

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: ImmunoIVD AB

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 7350134361789C
Device name: SPOT-it TREC & SMN1 Screening Kit
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Feb 17, 2025

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

2 UDI-DI variants

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Applied filters

basicUdiUlid01JMA33M2MKXQQNGT4742WKV9Y

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

4-2020-TS37350134361787
12-2020-TS47350134361784