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OraQuick HIV Self-Test

1001-0601U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001518
Basic UDI-DI: B-00608337001518
Reference: 1001-0601U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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OraQuick HIV Self-Test

1001-0600U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001273
Basic UDI-DI: B-00608337001273
Reference: 1001-0600U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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OraQuick SAMOTEST NA HIV

1001-0630U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001068
Basic UDI-DI: B-00608337001068
Reference: 1001-0630U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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OraQuick HCV Rapid Antibody Test

3001-2141

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000566
Basic UDI-DI: B-00608337000566
Reference: 3001-2141
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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OraQuick® HCV Rapid Antibody Test Kit Controls

1001-0278

IVD Annex II List AIVDDOn the marketHuman tissuesNear-patient testingProfessional testing

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000528
Basic UDI-DI: B-00608337000528
Reference: 1001-0278
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

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TEST AUTODIAGNOSTICO HELICOBACTER PYLORI

IVD self-testing devicesNot specifiedOn the market

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-801016NM
Basic UDI-DI: B-801016NM
Reference: 801016
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:45

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Test autodiagnostico Celiachia

IVD self-testing devicesNot specifiedOn the market

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-101177LK
Basic UDI-DI: B-101177LK
Reference: 101177-x
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 22:42

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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OdonAssist

Class IMDR 2017/745On the marketContains latexSingle useSterile

Manufacturer: Maternal Newborn Health Innovations Singapore Pte Ltd
Manufacturer SRN: SG-MF-000035955
UDI-DI: 18881300626010
Basic UDI-DI: 8881300626ODONASSISTU2
Reference: CAT-126
EMDN: U1004
EMDN description: MANUAL OBSTETRICAL EXTRACTORS, SINGLE-USE
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 21:10

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VENUS SHELL

Class IMDR 2017/745On the marketDirect marking

Manufacturer: HeroSupport
Manufacturer SRN: CH-MF-000051519
UDI-DI: 07649997674011
Basic UDI-DI: 7649997674VSZ5
Reference: VS1
EMDN: Z12011280
EMDN description: PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 06:56

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07649988168413

retinaWISE

Class IMDR 2017/745On the marketActive device

Manufacturer: Oculox Technologies SA
Manufacturer SRN: CH-MF-000038775
UDI-DI: 07649988168413
Basic UDI-DI: 76499881684RetinaWiseRL
Reference: A001-007-v03
EMDN: Q0299
EMDN description: OPHTHALMIC DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 06:49

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