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

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Merlin Assay

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: SkylineDx B.V.
Manufacturer SRN: NL-MF-000021406
UDI-DI: D-DM010334EUN00M4
Basic UDI-DI: B-DM010334EUN00M4
Reference: DM010334EUN00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 10.08.2026 10:00

Manufacturer products View details

CeliaSCAN

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Microbe&Lab B.V.
Manufacturer SRN: NL-MF-000005727
UDI-DI: 08719327031834
Basic UDI-DI: B-08719327031834
Reference: 2331633
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

Universal Sequencing Reaction Kit G400 SM FCS PE150

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130190
Basic UDI-DI: 697431813S-KitMW
Reference: 1000022485
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

K019-FactorV / Prothrombin

K019-Factor V / Prothrombin

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430409
Basic UDI-DI: B-04262420430409
Reference: K019
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

HLA-Ready Gene B27

HLA Ready Gene B27

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483168
Basic UDI-DI: B-04260152483168
Reference: 002058096
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene B57

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483137
Basic UDI-DI: B-04260152483137
Reference: 002 062 032
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene Coeliac Disease

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483120
Basic UDI-DI: B-04260152483120
Reference: 002 061 032
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HLA-Ready Gene B27

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483090
Basic UDI-DI: B-04260152483090
Reference: 002 058 032
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

Pathogen Multiplex-PCR Library Prep Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760160
Basic UDI-DI: 697780576HSTAALIBGD7
Reference: AA03-01-96D
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Pathogen Multiplex-PCR Library Prep Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760306
Basic UDI-DI: 697780576HSTAALIBGD7
Reference: AA03-01-96D
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

50 tests/kit, 400 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468669
Basic UDI-DI: 5745000468EU01001100508G
Reference: EU0100110050
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 04.08.2026 21:45

Manufacturer products View details

08800069800014

U-TOP™ MSI Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SEASUN BIOMATERIALS Inc.
Manufacturer SRN: KR-MF-000047160
UDI-DI: 08800069800014
Basic UDI-DI: B-08800069800014
Reference: SS-5030
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Greece
Authorised representative: SOAR & PARTNERS Sp. z o.o.
Last updated: 04.08.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

06975491762000

20 tests/pac; 40 tests/pac

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491762000
Basic UDI-DI: B-06975491762000
Reference: 20 tests/pac
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802070

100 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802070
Basic UDI-DI: B-06930317802070
Reference: DNK-1901-23
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802063

50 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802063
Basic UDI-DI: B-06930317802063
Reference: DNK-1901-23
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802087

250 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802087
Basic UDI-DI: B-06930317802087
Reference: DNK-1901-23
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802056

250 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802056
Basic UDI-DI: B-06930317802056
Reference: DNK-1901-22
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802049

100 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802049
Basic UDI-DI: B-06930317802049
Reference: DNK-1901-22
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802032

50 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802032
Basic UDI-DI: B-06930317802032
Reference: DNK-1901-22
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801981

50 tests

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801981
Basic UDI-DI: B-06930317801981
Reference: DNK-1901-20
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details