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22 device results listed.

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D-697603130CGBS01ACKVM

CGBS01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CGBS01ACKVM
Basic UDI-DI: B-697603130CGBS01ACKVM
Reference: CGBS01A-AHG4E
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNVC-CED-04X8

Beta-haemolytic Group B Streptococcus Nucleic Acid Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-04X8
Basic UDI-DI: B-TD-HNVC-CED-04X8
Reference: /
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Group B Streptococcus Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST06N8
Basic UDI-DI: B-ST06N8
Reference: ST06011X, ST06012X, ST06013W
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Group B Streptococcus Real Time PCR Kit

JB20112NW-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB20112NW-50TNC
Basic UDI-DI: B-JB20112NW-50TNC
Reference: JB20112NW-50T
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Group B Streptococcus Real Time PCR Kit

JB20112NW-25T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB20112NW-25TNC
Basic UDI-DI: B-JB20112NW-25TNC
Reference: JB20112NW-25T
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Great Basin Group B Streptococcus Test

300781

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395GBGBSKH
Basic UDI-DI: B-888501395GBGBSKH
Reference: 300781
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens Strep B qPCR Kit

LYO111WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115801289
Basic UDI-DI: B-08685115801289
Reference: LYO111
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RevoDx Streptococcus agalactiae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213479
Basic UDI-DI: B-08684387213479
Reference: IP202251-500
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:57

Manufacturer products View details

Xpert®

Xpert® GBS

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: D-07332940000127FC
Basic UDI-DI: B-07332940000127FC
Reference: GXGBS-100N-10
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 07.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560242

Group B Streptococcus (GBS) Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560242
Basic UDI-DI: B-06974858560242
Reference: P123H
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart GBS Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392477
Basic UDI-DI: B-06974767392477
Reference: 6018027105-CE
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ Lyocart GBS Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767392453
Basic UDI-DI: B-06974767392453
Reference: 6018027102-CE
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012917

PCR-based Group B Streptococcus Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012917
Basic UDI-DI: B-06974323012917
Reference: ID020
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012900

PCR-based Group B Streptococcus Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012900
Basic UDI-DI: B-06974323012900
Reference: ID020
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

Toda Strepdiag B 1

Toda Strepdiag B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309513249
Basic UDI-DI: B-03760309513249
Reference: 1010-1
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:59

Manufacturer products View details

Toda Strepdiag B 10

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309513232
Basic UDI-DI: B-03760309513232
Reference: 1010-10
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:59

Manufacturer products View details

Panther Fusion GBS Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510890
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04484
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
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

BIOSYNEX AMPLIFLASH GBS

IVD Class CIVDR 2017/746No longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678599700
Basic UDI-DI: 353267F00157P8N
Reference: 3150072
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

Panther Fusion GBS Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510906
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04485
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY 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

06955792700901

Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792700901
Basic UDI-DI: 69557927S3056E000001S7
Reference: S3056E-48
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details