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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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Optitrol HEPR-1 — 4 UDI-DI variants, IVDR (DiaMex GmbH)

MD Atlas
DiaMex GmbH

Data from EUDAMED, last updated May 23, 2026

Optitrol HEPR-1

426046567SRHEPRJK

4 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: DiaMex GmbH

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: 426046567SRHEPRJK
Device name: Optitrol HEPR-1
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Apr 22, 2025

Manufacturer & authorised representative

Manufacturer

Name: DiaMex GmbH
SRN: DE-MF-000037219
Country: Germany
Email: CDx-Info@lgcgroup.com
Phone: +1 508-244-6400

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01JSEYXSNPDZEE3PCJH73YC114

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

SR120454260465670422
SR120474260465670439
SR120554260465670446
SR120574260465670453