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

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01.08.2026 06:24

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25 device results listed.

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Leishmania infantum IgG ELISA

Leishmania infantum IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Bordier Affinity Products SA
Manufacturer SRN: CH-MF-000025247
UDI-DI: 07640158219508
Basic UDI-DI: 76401582195002Q
Reference: 9500
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: France
Authorised representative: Leman Diagnostics SARL
Last updated: 31.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test Cassette

Leishmania 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-ILEI-402EK
Basic UDI-DI: B-ILEI-402EK
Reference: ILEI-402
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG IgM Rapid Test

Leishmania 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: 69743840310320
Basic UDI-DI: B-69743840310320
Reference: 3023301
EMDN: W0105050205
EMDN description: LEISHMANIA
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

Leishmania infantum IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586410I
Basic UDI-DI: B-+ENTIRE586410I
Reference: RE58641
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTILEIG0310DS0O

NovaLisa® Leishmania infantum IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEIG0310DS0O
Basic UDI-DI: B-+ENTILEIG0310DS0O
Reference: LEIG0310DS
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEIG03100Q

NovaLisa® Leishmania infantum IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEIG03100Q
Basic UDI-DI: B-+ENTILEIG03100Q
Reference: LEIG0310
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIEIA-384306

Leishmania infantum IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-384306
Basic UDI-DI: B-+ENTIEIA-384306
Reference: EIA-3843
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDEIG03100I

Leishmania infantum IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDEIG03100I
Basic UDI-DI: B-+ENTIDEIG03100I
Reference: DEIG0310
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

Leishmania Real Time PCR Kit

YJB30123NW-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB30123NW-50TXU
Basic UDI-DI: B-YJB30123NW-50TXU
Reference: YJB30123NW-50T
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:03

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania Real Time PCR Kit

YJB30123NW-25T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB30123NW-25TXU
Basic UDI-DI: B-YJB30123NW-25TXU
Reference: YJB30123NW-25T
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:03

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test Cassette

Leishmania 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-ILEI-R4027J
Basic UDI-DI: B-ILEI-R4027J
Reference: ILEI-R402
EMDN: W0105050205
EMDN description: LEISHMANIA
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

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

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-T402aYL
Basic UDI-DI: B-GCKal-T402aYL
Reference: GCKal-T402a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

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

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-T402aHGQK
Basic UDI-DI: B-GCKal-T402aHGQK
Reference: GCKal-T402a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-402aNM
Basic UDI-DI: B-GCKal-402aNM
Reference: GCKal-402a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-402aHGWR
Basic UDI-DI: B-GCKal-402aHGWR
Reference: GCKal-402a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-401aNJ
Basic UDI-DI: B-GCKal-401aNJ
Reference: GCKal-401a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-401aHGWJ
Basic UDI-DI: B-GCKal-401aHGWJ
Reference: GCKal-401a
EMDN: W0105050205
EMDN description: LEISHMANIA
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

LEISHMANIA WB IgG

LEISHMANIA WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277934272K
Basic UDI-DI: B-37700277934272K
Reference: LES-WB96G
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

Manufacturer products View details

LEISHMANIA WB IgG

LEISHMANIA WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779340325
Basic UDI-DI: B-377002779340325
Reference: LES-WB12G
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

Manufacturer products View details

LEISHMANIA WB IgG

LEISHMANIA WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779341022
Basic UDI-DI: B-377002779341022
Reference: LES-WB24G
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

Manufacturer products View details