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100 device results listed.

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Chemtrue ®® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold)

COVID-19/Influenza A+B Ag Combo Rapid Test ( Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180720006LY
Basic UDI-DI: B-CNM0000180720006LY
Reference: 8041C
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Chemtrue ®® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)

COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180720005LW
Basic UDI-DI: B-CNM0000180720005LW
Reference: 8045C
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Chemtrue ® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)

COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180720004LU
Basic UDI-DI: B-CNM0000180720004LU
Reference: 8043C
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Reveal Rapid HIV Test

815311000577 HIV POC

IVD Annex II List AIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MedMira Laboratories Inc.
Manufacturer SRN: CA-MF-000013928
UDI-DI: D-81531100057769
Basic UDI-DI: B-81531100057769
Reference: 815311000577
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

08057723370592

SMART SNP Sample Diluent

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370592
Basic UDI-DI: B-08057723370592
Reference: SNPD-SD
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370561

SensiQuant Direct CELL Buffer

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370561
Basic UDI-DI: B-08057723370561
Reference: SQTd-CB
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

Trichomonas/Candida Antigen Combo Rapid Test Kit (Colloidal gold method)

CR027

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473306140
Basic UDI-DI: B-06974473306140
Reference: CR027
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/IL-6 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

CR042

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304061
Basic UDI-DI: B-06974473304061
Reference: CR042
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

SAA/CRP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

CR041

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473302036
Basic UDI-DI: B-06974473302036
Reference: CR041
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

RF-Absorbent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325025172
Basic UDI-DI: B-04049325025172
Reference: KIRF561
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

RIDA®Prep Tissue Digestion Kit

Buffers (Unassignable ), Supplem. Reagents, etc

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006197
Basic UDI-DI: 93430440W01059002015C
Reference: 90241
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

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