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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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OPA Discs — 3 UDI-DI variants, IVDR (RefLab Aps)

MD Atlas
RefLab Aps

Data from EUDAMED, last updated May 31, 2026

OPA Discs

574400328OPAHN

3 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: RefLab Aps

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 574400328OPAHN
Device name: OPA Discs
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 24, 2022

Manufacturer & authorised representative

Manufacturer

Name: RefLab Aps
SRN: DK-MF-000021844
Country: Denmark
Email: info@reflab.dk
Phone: +45 7070 2345

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01G3BCWW6NKZA5HK9X9B1ZYBFX

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

OPA Disc 25 mg, 100 pcs05744003280209
OPA Disc 25 mg, 20 pcs05744003280193
OPA Disc 5 mg, 10 pcs05744003280216