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109 device results listed.

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STANDARD™ M10 Stool Pretreatment kit

M10-STP-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111718557
Basic UDI-DI: 88001117IPAA01MA13W9
Reference: 11PRT20A
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Sputum Pretreatment Kit

M10-SPTP-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111718540
Basic UDI-DI: 88001117IPAA01MA11W5
Reference: M10-SPTP-01/11PRT10A
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

AFDF Kit - Alpha Defensin

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: I.T.A.-Intertact s.r.o.
Manufacturer SRN: CZ-MF-000003664
UDI-DI: 08594218270017
Basic UDI-DI: 859421827AFDF164620BF
Reference: 164620
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:52

Manufacturer products View details

NL SOLUTION

HK038X050

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074301910
Basic UDI-DI: 805750743HK0386D
Reference: HK038X050
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:49

Manufacturer products View details

NL SOLUTION (Prefilled)

HK043X020

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074301774
Basic UDI-DI: 805750743HK04366
Reference: HK043X020
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:49

Manufacturer products View details

mariPOC® Extraction solution B

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370368
Basic UDI-DI: 643008037B03BXN
Reference: B03B
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Extraction solution A

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370351
Basic UDI-DI: 643008037B03AXL
Reference: B03A
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

Aptima Transfer Solution

Reagents and Fluids

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045508606
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: 303658
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

β-Glucan Sample Diluent

999-04301

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163819
Basic UDI-DI: 498748114987481163819ZU
Reference: 999-04301
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

04049095000058

RIDASCREEN® TDM Wash buffer 20x

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095000058
Basic UDI-DI: 40490953096P00VK0W4
Reference: 3096P00-VK
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

04049095000041

RIDASCREEN® Control -

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095000041
Basic UDI-DI: 40490953056C00VK0NF
Reference: 3056C00-VK
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

04049095000034

RIDASCREEN® Stop

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095000034
Basic UDI-DI: 40490953080V00VK0UR
Reference: 3080V00-VK
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

04049095000027

RIDASCREEN® Wash buffer 10x

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095000027
Basic UDI-DI: 40490953029P00VK0TJ
Reference: 3029P00-VK
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

04049095000010

RIDASCREEN® Substrate

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095000010
Basic UDI-DI: 40490953019V01VK0VL
Reference: 3019V01-VK
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

04049095000003

RIDASCREEN® Diluent 1

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095000003
Basic UDI-DI: 40490953010P01VK0ND
Reference: 3010P01-VK
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

06970664752291

Multiple Real-time PCR kit for Detection of Respiratory Viruses

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664752291
Basic UDI-DI: B-06970664752291
Reference: 25Tests/Kit
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Specimen Diluent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509177
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-03003
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima DBS Extraction Buffer

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045511811
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04772
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Transport Medium

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510937
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04943
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Transport Medium

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510944
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04944
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details