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58 device results listed.

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06974858560587

Bacillus Pertussis 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: 06974858560587
Basic UDI-DI: B-06974858560587
Reference: P088H
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012061

Duplex Real-time PCR Detection Kit for Bordetella Pertussis

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012061
Basic UDI-DI: B-06974323012061
Reference: A2472-50T
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012054

Duplex Real-time PCR Detection Kit for Bordetella Pertussis

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012054
Basic UDI-DI: B-06974323012054
Reference: A2472-25T
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella Pertussis & Bordetella Parapertussis Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227769
Basic UDI-DI: B-06971042227769
Reference: RD-0266-02
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella Pertussis Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227653
Basic UDI-DI: B-06971042227653
Reference: RD-0061-02
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLEX® Bordetella pertussis/parapertussis, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008533
Basic UDI-DI: B-04050598008533
Reference: KG190996
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:47

Manufacturer products View details

MutaPLEX® Bordetella pertussis/parapertussis, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003484
Basic UDI-DI: B-04050598003484
Reference: KG190932
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:43

Manufacturer products View details

04049095160325

RIDA®GENE Bordetella

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095160325
Basic UDI-DI: B-04049095160325
Reference: PG2505
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:06

Manufacturer products View details

Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)

5.182.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003122
Basic UDI-DI: 84295775182XE
Reference: 5.182.096.88.000
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003139
Basic UDI-DI: 84295775182XE
Reference: 5.182.048.88.000
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

04049095210174

RIDA®UNITY Bordetella

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210174
Basic UDI-DI: 4049095UN25050000R6
Reference: UN2505
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

BIOSYNEX AMPLIQUICK Bordetella

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593685
Basic UDI-DI: 353267F00133P7Y
Reference: 3150068_SEC01
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

EasyNAT BP Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240176
Basic UDI-DI: 697349224U2020092C000GU
Reference: U20209
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - 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

Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731929
Basic UDI-DI: B-06955792731929
Reference: S3136E-48
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731912
Basic UDI-DI: B-06955792731912
Reference: S3136E-24
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731622

Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731622
Basic UDI-DI: B-06955792731622
Reference: S3055E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731615
Basic UDI-DI: B-06955792731615
Reference: S3055E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX AMPLIQUICK Bordetella

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593692
Basic UDI-DI: 353267F00133P7Y
Reference: 3150068_SEC02
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details