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241 device results listed.

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BBL

BD BBL™ Streptocard™ Test Cards

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409281
Basic UDI-DI: 038290KOUWIZATNC
Reference: 240928
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Test Latex A

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409236
Basic UDI-DI: 038290GGXDCGRW7W
Reference: 240923
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

BBL Streptocard

BD BBL™ Streptocard™ Enzyme Latex Test Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409182
Basic UDI-DI: 038290MPOMLCHHF6
Reference: 240918
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

BBL Streptocard

BD BBL™ Streptocard™ Acid Latex Test Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409175
Basic UDI-DI: 038290INMITSBFD4
Reference: 240917
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

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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

D-TD-HNVC-CED-03X6

Beta-haemolytic Group A 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-03X6
Basic UDI-DI: B-TD-HNVC-CED-03X6
Reference: /
EMDN: W0105011103
EMDN description: STREP. A 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

GenomEra® S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-70-01-40VW
Basic UDI-DI: B-CDX-70-01-40VW
Reference: CDX-70-01-40
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-70-01-40URA
Basic UDI-DI: B-CDX-70-01-40URA
Reference: CDX-70-01-40
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-70-01-20VQ
Basic UDI-DI: B-CDX-70-01-20VQ
Reference: CDX-70-01-20
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-70-01-20UQY
Basic UDI-DI: B-CDX-70-01-20UQY
Reference: CDX-70-01-20
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® GBS Assay Kit

CDX-60

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-60-01-40VB
Basic UDI-DI: B-CDX-60-01-40VB
Reference: CDX-60-01-40
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra GBS Assay Kit

CDX-60

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-60-01-40UQK
Basic UDI-DI: B-CDX-60-01-40UQK
Reference: CDX-60-01-40
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® GBS Assay Kit

CDX-60

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-60-01-20V5
Basic UDI-DI: B-CDX-60-01-20V5
Reference: CDX-60-01-20
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra GBS Assay Kit

CDX-60

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-60-01-20UQ9
Basic UDI-DI: B-CDX-60-01-20UQ9
Reference: CDX-60-01-20
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products 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

S. PneumoStrip

3.165.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773165WYH9
Basic UDI-DI: B-84295773165WYH9
Reference: 3.165.XXX.YY.ZZZ
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-81649002RGAS01JKST

RGAS01-AHG5E/ RGAS01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002RGAS01JKST
Basic UDI-DI: B-81649002RGAS01JKST
Reference: RGAS01-AHG5E/ RGAS01-AHG25E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY 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