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86 device results listed.

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Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma)

GCTB-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTB-302aZC
Basic UDI-DI: B-GCTB-302aZC
Reference: GCTB-302a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

CARBA 5 In 1 Rapid Test Cassette

GCCRE-T1402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCRE-T1402a25
Basic UDI-DI: B-GCCRE-T1402a25
Reference: GCCRE-T1402a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Verotoxin 1+2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275304
Basic UDI-DI: B-86060313275304
Reference: C1810V24VERT
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360386316313EM
Basic UDI-DI: B-084360386316313EM
Reference: 101-0424
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:30

Manufacturer products View details

Typhoid IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold)

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402017
Basic UDI-DI: B-06977698402017
Reference: GKPD037
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM Rapid Test Strip(whole blood/serum/plasma)

A100501S

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753472712
Basic UDI-DI: B-06976753472712
Reference: A100501S
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae Antigen Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620773
Basic UDI-DI: B-06974854620773
Reference: P2202725
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cholera O1 Antigen Rapid Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303575
Basic UDI-DI: B-06974566303575
Reference: RCO-602
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O1 Rapid Test Kit (Colloidal gold method)

CR037

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304788
Basic UDI-DI: B-06974473304788
Reference: CR037
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

Bacterial vaginosis Rapid Test Kit (Colloidal gold method)

CR028

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304047
Basic UDI-DI: B-06974473304047
Reference: CR028
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

Typhoid Antigen Rapid Test Kit (Colloidal gold method)

CR021

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473303132
Basic UDI-DI: B-06974473303132
Reference: CR021
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)

CR020

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473301350
Basic UDI-DI: B-06974473301350
Reference: CR020
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

Vibrio Cholerae O1/O139 Rapid Test Kit (Colloidal gold method)

CR036

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473300698
Basic UDI-DI: B-06974473300698
Reference: CR036
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

06974323018711

Vibrio Cholerae O1/O139 Antigens Rapid Test Cassette(Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018711
Basic UDI-DI: B-06974323018711
Reference: IH019
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018704

Vibrio Cholerae O1/O139 Antigens Rapid Test Cassette(Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018704
Basic UDI-DI: B-06974323018704
Reference: IH019
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018698

Vibrio Cholerae O1/O139 Antigens Rapid Test Cassette(Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018698
Basic UDI-DI: B-06974323018698
Reference: IH019
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911060
Basic UDI-DI: B-06974238911060
Reference: HCAL056G
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans, Trichomonas vaginalis and Gardnerella Vaginalis Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910728
Basic UDI-DI: B-06974238910728
Reference: HTCG070G
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Vibrio Cholerae O1/O139 Antigen Combo Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850457
Basic UDI-DI: B-06973181850457
Reference: 501070
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

Fuller Laboratories by VMRD Orientia tsutsugamushi MIF IgM Antibody Kit

OTM-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VMRD, Inc.
Manufacturer SRN: US-MF-000049394
UDI-DI: 00850078245205
Basic UDI-DI: B-00850078245205
Reference: OTM-100
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Finland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details