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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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68 device results listed.

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Truenat Malaria Pv/Pf

601010050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989330
Basic UDI-DI: B-08908007989330
Reference: 601010050
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Malaria Pv/Pf

601010020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989323
Basic UDI-DI: B-08908007989323
Reference: 601010020
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat® Malaria Pv/Pf

601010005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989316
Basic UDI-DI: B-08908007989316
Reference: 601010005, 601010020,601010025, 601010050
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat H1N1

601070020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989057
Basic UDI-DI: B-08908007989057
Reference: 601070020
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat H1N1

601070005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989040
Basic UDI-DI: B-08908007989040
Reference: 601070005, 601070020, 601070025, 601070050
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

STABILYSE Prep Free

90101PF05, 90101PF20, 90101PF25, 90101PF50

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139637
Basic UDI-DI: 890802013964456
Reference: 90101PF20
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep® AUTO v2

603042001

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

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989972
Basic UDI-DI: 8908007989972DA
Reference: 603042001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Truelab® Quattro

603023001

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

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989965
Basic UDI-DI: 8908007989965DD
Reference: 603023001
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Truelab® Duo

603022001

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

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989958
Basic UDI-DI: 8908007989958DG
Reference: 603022001
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Truelab® Uno Dx

603021001

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

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989941
Basic UDI-DI: 8908007989941CX
Reference: 603021001
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO Universal Sample Pre-treatment Pack

60205AB05, 60205AB20, 60205AB25, 60205AB50

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989927
Basic UDI-DI: 89080201395835B
Reference: 60205AB20
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO MTB Sample Pre-treatment Pack

60204AS05, 60204AS20, 60204AS25, 60204AS50

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989903
Basic UDI-DI: 89080201395765E
Reference: 60204AS20
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO Universal Cartridge Based Sample Prep Kit

60203AR25, 60203AR50

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989880
Basic UDI-DI: 8908007989880D4
Reference: 60203AR25
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO Transport Medium for Swab Specimen Pack

60206TS05, 60206TS20,60206TS25, 60206TS50

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989866
Basic UDI-DI: 890802013959058
Reference: 60206TS20
EMDN: W05020199
EMDN description: SAMPLES TRANSPORT, CONTAINERS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit

60207AR50

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989859
Basic UDI-DI: 8908007989859DD
Reference: 60207AR50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO MTB Sample Pre-treatment Pack

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139576
Basic UDI-DI: 89080201395765E
Reference: 60204AS25
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO MTB Sample Pre-treatment Pack

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139903
Basic UDI-DI: 89080201395765E
Reference: 60204AS05
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO Universal Cartridge Based Sample Prep Kit

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989897
Basic UDI-DI: 8908007989880D4
Reference: 60203AR50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO MTB Sample Pre-treatment Pack

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989910
Basic UDI-DI: 89080201395765E
Reference: 60204AS50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Trueprep AUTO Transport Medium for Swab Specimen Pack

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139590
Basic UDI-DI: 890802013959058
Reference: 60206TS25
EMDN: W05020199
EMDN description: SAMPLES TRANSPORT, CONTAINERS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details