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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 18:27

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739 device results listed.

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2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515304W3
Basic UDI-DI: B-0320515304W3
Reference: 0320515304
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515303VZ
Basic UDI-DI: B-0320515303VZ
Reference: 0320515303
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515302VX
Basic UDI-DI: B-0320515302VX
Reference: 0320515302
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515301VV
Basic UDI-DI: B-0320515301VV
Reference: 0320515301
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

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Free Beta HCG (eCLIA)

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515104VR
Basic UDI-DI: B-0320515104VR
Reference: 0320515104
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

Free Beta HCG (eCLIA)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515103VP
Basic UDI-DI: B-0320515103VP
Reference: 0320515103
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

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Free Beta HCG (eCLIA)

2×50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515102VM
Basic UDI-DI: B-0320515102VM
Reference: 0320515102
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

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Free Beta HCG (eCLIA)

50T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-0320515101VK
Basic UDI-DI: B-0320515101VK
Reference: 0320515101
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 05.07.2026 16:32

Manufacturer products Authorised representative products Authorised representative actors View details

AL-105-I - AMHG ELISA

AL-105

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-00853592008004HD
Basic UDI-DI: B-00853592008004HD
Reference: AL-105
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 05.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Test Kit (Fluorescence Immunoassay)

β-HCG Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807177094RC
Basic UDI-DI: B-000012807177094RC
Reference: HWTS-PF009
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465235470
Basic UDI-DI: 697846523HormoneB10HQ
Reference: 2×100 test
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin beta subunit Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465234770
Basic UDI-DI: 697846523HormoneB12HU
Reference: 2×100 test
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

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40 tests/kit 100 tests/kit 200 tests/kit

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025453
Basic UDI-DI: 697648502AMHUB
Reference: 10-2227 40 tests/kit
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485022933
Basic UDI-DI: 697648502HCGUE
Reference: 10-2117 40 tests/kit
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:39

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β-Human Chorionic Gonadotropin Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500096
Basic UDI-DI: 697518250P117076T
Reference: P11710
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ BETA-HCG

HOKAPI™ BETA-HCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404991
Basic UDI-DI: 697139043040988
Reference: 010409001
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HCG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404977
Basic UDI-DI: 697139043040886
Reference: 010408001
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

AMH CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577171900
Basic UDI-DI: 697015090000047HA
Reference: CMS0501
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AMH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716401808
Basic UDI-DI: 693971640412LJ
Reference: 010412401
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

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Total β- Human Chorionic Gonadotropin (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605356
Basic UDI-DI: 69268026MD761F0000000013C
Reference: MCL05801E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details