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219 device results listed.

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Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST01MW
Basic UDI-DI: B-ST01MW
Reference: ST01021V, ST01022U
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test Strip (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGVPH-501aLF
Basic UDI-DI: B-OGVPH-501aLF
Reference: VPH-501a
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

STI-Q comprehensive Real Time PCR Kit

G2M803721

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803721FY
Basic UDI-DI: B-G2M803721FY
Reference: G2M803721,G2M803721R
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

STI7-Q Real-Time PCR Kit

G2M709121

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M709121FX
Basic UDI-DI: B-G2M709121FX
Reference: G2M709121,G2M709121R
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

STD Panel Strip

3.150.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773150WKFD
Basic UDI-DI: B-84295773150WKFD
Reference: 3.150.XXX.YY.ZZZ
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-81649002CSTIZK01AKWVB

CSTIZK01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CSTIZK01AKWVB
Basic UDI-DI: B-81649002CSTIZK01AKWVB
Reference: CSTIZK01A-AHG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CGCT01ACLRC

CGCT01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CGCT01ACLRC
Basic UDI-DI: B-81649002CGCT01ACLRC
Reference: CGCT01A-AHG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Urinogenital and Resistance 12 well Step 1

RIDA®Plex Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006951
Basic UDI-DI: B-09343044006951
Reference: 87123S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Urinogenital and Resistance 12 well Step 2

RIDA®Plex Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006944
Basic UDI-DI: B-09343044006944
Reference: 87123P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Urinogenital and Resistance 12 well Step 1

RIDA®Plex Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006937
Basic UDI-DI: B-09343044006937
Reference: 27123S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Urinogenital and Resistance 12 well Step 2

RIDA®Plex Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006920
Basic UDI-DI: B-09343044006920
Reference: 27123P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Urinogenital 8 well Step 1

RIDA®Plex Urinogenital 8 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006890
Basic UDI-DI: B-09343044006890
Reference: 27113S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Urinogenital 8 well Step 2

RIDA®Plex Urinogenital 8 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006883
Basic UDI-DI: B-09343044006883
Reference: 27113P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex STI 16 well Step 1

RIDA®Plex STI 16 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006876
Basic UDI-DI: B-09343044006876
Reference: 27112S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex STI 16 well Step 2

RIDA®Plex STI 16 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006869
Basic UDI-DI: B-09343044006869
Reference: 27112P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Urinogenital and Resistance 12-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004940
Basic UDI-DI: B-09343044004940
Reference: 87123S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Urinogenital and Resistance 12-well

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004933
Basic UDI-DI: B-09343044004933
Reference: 87123P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002861
Basic UDI-DI: B-09343044002861
Reference: 27123S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Urinogenital and Resistance 12 well

Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002854
Basic UDI-DI: B-09343044002854
Reference: 27123P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Urinogenital (8-well)

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002229
Basic UDI-DI: B-09343044002229
Reference: 27113S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details