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495 device results listed.

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Alethia

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733101663
Basic UDI-DI: 008407331ALETHIACLA001QV
Reference: 610189
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

SAMBA III Tablet Module

I190007TM

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Diagnostics for the Real World (Europe) Ltd.
Manufacturer SRN: UK-MF-000047660
UDI-DI: G763I190007TM0
Basic UDI-DI: ++G763I190007TM3C
Reference: I190007TM
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

SAMBA III Assay Module

I190007AM

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Diagnostics for the Real World (Europe) Ltd.
Manufacturer SRN: UK-MF-000047660
UDI-DI: ++G763I190007AM0
Basic UDI-DI: ++G763I190007AMZG
Reference: I190007AM
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4M1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014360505
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4M1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4М3

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362370
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4M3-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4М6

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362387
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4M6-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 5М3

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362417
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5M3-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 5М6

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362424
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5M6-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4Х1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362363
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4Х1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 5Х1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362400
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5Х1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTlite 5S1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014360529
Basic UDI-DI: 466001436DA01ZL
Reference: O-DTLITE5S1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002MNAP01JGSA

MNAP01

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002MNAP01JGSA
Basic UDI-DI: B-81649002MNAP01JGSA
Reference: MNAP01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 9L4

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366330
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream9L4-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 12L1

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366347
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream12L1-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 12L4

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366354
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream12L4-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 15L1

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366361
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream15L1-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 15L4

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366378
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream15L4-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 9М1

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366385
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream9М1-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 9М4

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366392
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream9М4-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 12М1

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366408
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream12M1-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details