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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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SOPHiA GENETICS™ Dx Universal Library… — 8 UDI-DI variants, IVDR

MD Atlas
SOPHiA GENETICS SA

Data from EUDAMED, last updated May 31, 2026

SOPHiA GENETICS™ Dx Universal Library Prep

7622283ULPDx7A

8 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: SOPHiA GENETICS SA

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 7622283ULPDx7A
Device name: SOPHiA GENETICS™ Dx Universal Library Prep
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: SOPHiA GENETICS SA
SRN: CH-MF-000025221
Country: Switzerland
Email: support@sophiagenetics.com

Authorised representative

Name: SOPHiA GENETICS SAS
SRN: FR-AR-000022214
Country: France

Variants by status

UDI-DI variants

8 UDI-DI variants

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Applied filters

basicUdiUlid01KSJFKA0PDX8QC0AJ7500R05J

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

BX6002UNICMDL3007622283013121
BX6002UNICMDL31-3207622283013176
BX6002UNICMDL30-9607622283013152
BX6002UNICMDL31-1607622283013169
BX6002UNICMDL30-4807622283013145
BX6002UNICMDL30-3207622283013138
BX6002UNICMDL31-9607622283013190
BX6002UNICMDL31-4807622283013183