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9 device results listed.

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Dr. PCR™ BCR-ABL1 Major IS Detection Kit

DON01-X

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940087
Basic UDI-DI: B-08809740940087
Reference: DON01-X
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

G_PCR Chip Case

CTG01-04

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940155
Basic UDI-DI: 880974094ACC01EB
Reference: CTG01-04
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA-M POWERBOX

LAM306-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940117
Basic UDI-DI: 880974094LAM306J3
Reference: LAM306-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA-M Module

LAM304-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940070
Basic UDI-DI: 880974094LAM304HX
Reference: LAM304-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA-M Powerbox System

LAM306-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940124
Basic UDI-DI: 8809740943M0069J
Reference: LAM306-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

08809740940063

LOAA-M Console

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940063
Basic UDI-DI: 880974094LAM303HV
Reference: LAM303-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA Analyzer

ONPOINT

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940025
Basic UDI-DI: 880974094LAM301HR
Reference: LAM301-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

D_PCR Chip Case

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940162
Basic UDI-DI: 880974094ACC01EB
Reference: CTD01-04
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. PCR 20K Cartridge -PF

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940179
Basic UDI-DI: 880974094ACC01EB
Reference: CTR002
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details