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

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811 device results listed.

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Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA)

C2KC011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051737
Basic UDI-DI: B-06971792051737
Reference: C2KC011
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin (HCG) Assay Reagent Kit (CMIA)

C2KC005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051614
Basic UDI-DI: B-06971792051614
Reference: C2KC005
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763220155
Basic UDI-DI: B-06971763220155
Reference: 0015-03
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

The β-subunit of Human Chorionic Gonadotropin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101832
Basic UDI-DI: B-06971354101832
Reference: RF16373-50T
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101825
Basic UDI-DI: B-06971354101825
Reference: RG16388-50T
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101580
Basic UDI-DI: B-06971354101580
Reference: RG16364-20T
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

The β-subunit of Human Chorionic Gonadotropin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100446
Basic UDI-DI: B-06971354100446
Reference: RF16135-20T
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100309
Basic UDI-DI: B-06971354100309
Reference: RF16219-50T
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100279
Basic UDI-DI: B-06971354100279
Reference: RF16133-20T
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo AMH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939762
Basic UDI-DI: B-06971225939762
Reference: KM32060
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go β-HCG Kit

FIA Go β-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936310
Basic UDI-DI: B-06971225936310
Reference: FIA20025
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo TB-HCG Kit

Kemilo TB-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935849
Basic UDI-DI: B-06971225935849
Reference: KM09018
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo TB-HCG Kit

Kemilo TB-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935832
Basic UDI-DI: B-06971225935832
Reference: KM09060
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go AMH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931308
Basic UDI-DI: B-06971225931308
Reference: FIA30025
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

β-humanchorionic gonadotrophin

β-Human Chorionic Gonadotropin Quantitative Test Kit (Fluorescence Immunochromatography)

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-06934175046287QW
Basic UDI-DI: B-06934175046287QW
Reference: 12600785
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Self Clear MK

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 05206977000035
Basic UDI-DI: B-05206977000035
Reference: ACO-01-001M
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Greece
Authorised representative: -
Last updated: 06.07.2026 08:29

Manufacturer products View details

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048017
Basic UDI-DI: 69449040004H-E3********T3
Reference: 105-004253-00
EMDN: W0102050202
EMDN description: ESTRIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Total β HCG Calibrators

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048314
Basic UDI-DI: 69449040004H-HCG-II****HG
Reference: 105-004290-00
EMDN: W0102050205
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estriol Calibrators

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048383
Basic UDI-DI: 69449040004H-E3********T3
Reference: 105-004297-00
EMDN: W0102050202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estrone ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030206
Basic UDI-DI: B-04049325030206
Reference: DB52051
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details