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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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PT Owren — 4 UDI-DI variants, IVDR (Nordic Biomarker AB)

MD Atlas
Nordic Biomarker AB

Data from EUDAMED, last updated May 31, 2026

PT Owren

7350060320036Q

4 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: Nordic Biomarker AB

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 7350060320036Q
Device name: PT Owren
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Apr 10, 2026

Manufacturer & authorised representative

Manufacturer

Name: Nordic Biomarker AB
SRN: SE-MF-000022201
Country: Sweden
Email: info@nordicbiomarker.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KNV7DHA7MXPAXZ36Z8ZAV4JZ

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

K502627350060320073
K506427350060320448
K502827350060320097
K502727350060320080