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VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217114
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS113LE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217121
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS113HE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

ChainFor™

CFP62

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257635
Basic UDI-DI: 868511580PCR35JD
Reference: CFP35P100
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217169
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS196TE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217138
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:48

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217145
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS136E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:48

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217152
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS172E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:48

Manufacturer products View details

Casete de prueba rápida de antígenos de Salmonella typhi y paratyphi

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-06942598207086UZ
Basic UDI-DI: B-06942598207086UZ
Reference: ISTP-625
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 18:20

Manufacturer products Authorised representative products Authorised representative actors View details

06928103011102

Large package, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103011102
Basic UDI-DI: B-06928103011102
Reference: DA1110
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.08.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Chlamydia pneumoniae IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ORGENTEC Diagnostika GmbH
Manufacturer SRN: DE-MF-000033178
UDI-DI: 04260157083578
Basic UDI-DI: B-04260157083578
Reference: ORG 907G
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440239246
Basic UDI-DI: 84354402_MDXRESIST_NCRMS
Reference: VS-NCR106L
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 16:41

Manufacturer products View details

RevoDx Escherichia coli qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717462
Basic UDI-DI: B-08683079717462
Reference: IP202205-100
EMDN: W0105011503
EMDN description: E. COLI DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 05.08.2026 15:03

Manufacturer products View details

GeneProof Treponema pallidum MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302429
Basic UDI-DI: B-08595696302429
Reference: TP/MC/190
EMDN: W0105010305
EMDN description: SYPHILIS DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 05.08.2026 14:50

Manufacturer products View details

GeneProof Treponema pallidum MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302412
Basic UDI-DI: B-08595696302412
Reference: TP/MC/038
EMDN: W0105010305
EMDN description: SYPHILIS DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 05.08.2026 14:50

Manufacturer products View details

Typhoid Ag Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140365
Basic UDI-DI: B-06958982140365
Reference: AB71-20
EMDN: W0105011099
EMDN description: SALMONELLA REAGENTS - OTHER
First on market country: Denmark
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140358
Basic UDI-DI: B-06958982140358
Reference: AB70-20
EMDN: W0105011099
EMDN description: SALMONELLA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

(MP) Mycoplasma Pneumoniae Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140297
Basic UDI-DI: B-06958982140297
Reference: AH61-20
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

(TB) Tuberculosis Test

Strips & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140259
Basic UDI-DI: B-06958982140259
Reference: AB50-11
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735996

Campylobacter fetus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735996
Basic UDI-DI: B-06955792735996
Reference: S3210E-24
EMDN: W0105011402
EMDN description: CAMPYLOBACTER DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735989

Campylobacter jejuni Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735989
Basic UDI-DI: B-06955792735989
Reference: S3209E-48
EMDN: W0105011402
EMDN description: CAMPYLOBACTER DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details