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219 device results listed.

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Anatolia Geneworks

Bosphore CT/NG/MG Panel Kit v1

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020570
Basic UDI-DI: 868001894PCRSTDCNMPN100E5
Reference: ABMNC3
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
Safety summary (SSCP/SSP): SSP Bosphore CT NG MG Panel Kit · Rev. v1
Authorised representative: -
Last updated: 30.06.2026 23:29

Manufacturer products Open in EUDAMED View details

Anatolia Geneworks

Bosphore CT/NG/MG Panel Kit v1

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020563
Basic UDI-DI: 868001894PCRSTDCNMPN100E5
Reference: ABMNC2
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
Safety summary (SSCP/SSP): SSP Bosphore CT NG MG Panel Kit · Rev. v1
Authorised representative: -
Last updated: 30.06.2026 23:29

Manufacturer products Open in EUDAMED View details

Anatolia Geneworks

Bosphore CT/NG/MG Panel Kit v1

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020556
Basic UDI-DI: 868001894PCRSTDCNMPN100E5
Reference: ABMNC1
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
Safety summary (SSCP/SSP): SSP Bosphore CT NG MG Panel Kit · Rev. v1
Authorised representative: -
Last updated: 30.06.2026 23:29

Manufacturer products Open in EUDAMED View details

TaqPath™ Menu | GeneProof™ MH/UU/UP Multiplex PCR Kit

GeneProof MH/UU/UP Multiplex PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304010
Basic UDI-DI: 859569630002Q5
Reference: A58123
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

TaqPath™ Menu | GeneProof™ CT/NG/MG Multiplex PCR Kit

GeneProof CT/NG/MG Multiplex PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696303952
Basic UDI-DI: 859569630012Q8
Reference: A58117
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof CT/NG/MG Multiplex PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301958
Basic UDI-DI: 859569630012Q8
Reference: CNMX/GP/025
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof CT/NG/MG Multiplex PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301941
Basic UDI-DI: 859569630012Q8
Reference: CNMX/GP/100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof MH/UU/UP Multiplex PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301651
Basic UDI-DI: 859569630002Q5
Reference: MUPX/GP/025
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof MH/UU/UP Multiplex PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301644
Basic UDI-DI: 859569630002Q5
Reference: MUPX/GP/100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

STD VIRPLEX® MINILAB PANEL

ML001

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290272
Basic UDI-DI: 843661029ML0010153
Reference: ML001
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: 30.06.2026 15:33

Manufacturer products View details

MH/UU/UP REALTIME PCR KIT

RTPCR026

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290128
Basic UDI-DI: 843661029RTPCR026018T
Reference: RTPCR026-LP
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: 30.06.2026 15:33

Manufacturer products View details

Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227856
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02S1
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: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227825
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02S1A
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: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227788
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02M1
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: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227771
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02L1
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: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227757
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02M1A
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: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227740
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02L1A
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: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT CT/NG Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240121
Basic UDI-DI: 697349224U2030012C000EB
Reference: U203001-20
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

06972412611799

Cassette

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611799
Basic UDI-DI: 697241261IGC-5259E
Reference: IGC-525
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Combo 2 Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512900
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05576
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details