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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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One Lambda Devyser Accept cfDNA — 2 UDI-DI variants, IVDR

MD Atlas
Devyser AB

Data from EUDAMED, last updated May 31, 2026

One Lambda Devyser Accept cfDNA

7350040638R114RC

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: Devyser AB

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 7350040638R114RC
Device name: One Lambda Devyser Accept cfDNA
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Mar 13, 2025

Manufacturer & authorised representative

Manufacturer

Name: Devyser AB
SRN: SE-MF-000001699
Country: Sweden
Email: info@deyvser.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01JP7JC1F6NVA0052JW7NSEWME

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

One Lambda Devyser Accept cfDNA07350040631751
One Lambda Devyser Accept cfDNA07350040631744