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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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OrthoPulse® — 3 UDI-DI variants, MDR (Biolux Technology GmbH)

MD Atlas
Biolux Technology GmbH

Data from EUDAMED, last updated May 23, 2026

OrthoPulse®

912011809OPiGN

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Biolux Technology GmbH

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 912011809OPiGN
Device name: OrthoPulse®
Device model: OrthoPulse
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jan 22, 2024

Manufacturer & authorised representative

Manufacturer

Name: Biolux Technology GmbH
SRN: AT-MF-000020789
Country: Austria
Email: info@bioluxtec.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01HMSCZEEAEVTKX87ZM2MVDH81

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

OrthoPulse 2.0E09120118090074
OrthoPulse 2.0S09120118090067
OrthoPulse Lite91201180900032