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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 01:12

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12 device results listed.

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Leptospira IgG IgM Rapid Test

Leptospira IgG IgM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310252
Basic UDI-DI: B-69743840310252
Reference: 3023201
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE589410L
Basic UDI-DI: B-+ENTIRE589410L
Reference: RE58941
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

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Leptospira IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE589310K
Basic UDI-DI: B-+ENTIRE589310K
Reference: RE58931
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

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+ENTILEPM066004

NovaLisa® Leptospira IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEPM066004
Basic UDI-DI: B-+ENTILEPM066004
Reference: LEPM0660
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEPG06600+

NovaLisa® Leptospira IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEPG06600+
Basic UDI-DI: B-+ENTILEPG06600+
Reference: LEPG0660
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEPM0660DS02

NovaLisa® Leptospira IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEPM0660DS02
Basic UDI-DI: B-+ENTILEPM0660DS02
Reference: LEPM0660DS
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

Leptospira IgG/IgM Rapid Test Cassette

Leptospira IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILEP-R402AD
Basic UDI-DI: B-ILEP-R402AD
Reference: ILEP-R402
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCLEP(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCLEP(IgG/IgM)-402aRF
Basic UDI-DI: B-GCLEP(IgG/IgM)-402aRF
Reference: GCLEP(IgG/IgM)-402a
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCLEP(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCLEP(IgG/IgM)-402aHG8L
Basic UDI-DI: B-GCLEP(IgG/IgM)-402aHG8L
Reference: GCLEP(IgG/IgM)-402a
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

A490501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475874
Basic UDI-DI: B-06976753475874
Reference: A490501D
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303148
Basic UDI-DI: B-06974566303148
Reference: ILP-422
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira Real Time PCR Kit

Leptospira Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042228919
Basic UDI-DI: B-06971042228919
Reference: ZD-0074-02
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details