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16 device results listed.

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K017a-Leptospira pathogenic (Ready to use PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430461
Basic UDI-DI: B-04262420430461
Reference: K017a
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

FR001-Leptospira pathogenic (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430287
Basic UDI-DI: B-04262420430287
Reference: FR001
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

D0007-DNA Positive Control for Leptospira

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430034
Basic UDI-DI: B-04262420430034
Reference: D0007
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

Leptospira Real Time PCR Kit

JB30101NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB30101NW-50TN7
Basic UDI-DI: B-JB30101NW-50TN7
Reference: JB30101NW-50T
EMDN: W0105011604
EMDN description: LEPTOSPIRA - 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

Leptospira Real Time PCR Kit

JB30101NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB30101NW-25TN7
Basic UDI-DI: B-JB30101NW-25TN7
Reference: JB30101NW-25T
EMDN: W0105011604
EMDN description: LEPTOSPIRA - 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

Truenat LTS

601400020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139194
Basic UDI-DI: B-08908020139194
Reference: 601400020
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat LTS

601400005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139187
Basic UDI-DI: B-08908020139187
Reference: 601400005, 601400020, 601400025, 601400050
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat LTS

601400050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139217
Basic UDI-DI: B-08908020139217
Reference: 601400050
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat LTS

601400025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139200
Basic UDI-DI: B-08908020139200
Reference: 601400025
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Leptospira spp qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215602
Basic UDI-DI: B-08684387215602
Reference: IP202525-100
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

Manufacturer products View details

RevoDx Leptospira spp qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215596
Basic UDI-DI: B-08684387215596
Reference: IP202525-25
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

Manufacturer products View details

Leptospira IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910292
Basic UDI-DI: B-06974238910292
Reference: HLEP002T
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Leptospira Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930658
Basic UDI-DI: 89080153043B249NR
Reference: 3B249/C
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX AMPLIQUICK Leptospira

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593197
Basic UDI-DI: 353267F00057P8F
Reference: 3150064
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

TRUPCR® Leptospira Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930665
Basic UDI-DI: 89080153043B249NR
Reference: 3B249
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Leptospira Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930672
Basic UDI-DI: 89080153043B249NR
Reference: 3B230
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details