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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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Sample Collection Kit — 9 UDI-DI variants, IVDR

MD Atlas
IGENOMIX SPAIN LAB S.L UNIPERSONAL

Data from EUDAMED, last updated May 23, 2026

Sample Collection Kit

8437021231P2D8

9 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: IGENOMIX SPAIN LAB S.L UNIPERSONAL

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 8437021231P2D8
Device name: Sample Collection Kit
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Sep 7, 2023

Manufacturer & authorised representative

Manufacturer

Name: IGENOMIX SPAIN LAB S.L UNIPERSONAL
SRN: ES-MF-000029287
Country: Spain
Email: Vigilance@vitrolife.com
Phone: 96 390 53 10

Variants by status

UDI-DI variants

9 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01H7AC2R5XWM0Y101QN62JMYD4

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

Kit Blood 108437021231069
Kit Blood 208437021231076
Kit Buccal swab CR108437021231090
Kit Buccal swab CR208437021231106
Kit Buccal swab SR208437021231137
Kit POC I08437021231144
Kit Saliva 108437021231083
Kit Saliva 208437021231151
Kit SAT08437021231038