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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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969 device results listed.

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hCG Pregnancy Rapid Test

GHHCG

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762128
Basic UDI-DI: B-06976202762128
Reference: GHHCG-B502
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463365
Basic UDI-DI: B-06975132463365
Reference: FCG-102G-25
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463358
Basic UDI-DI: B-06975132463358
Reference: FCG-102G-1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463341
Basic UDI-DI: B-06975132463341
Reference: FCG-103G-1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463334
Basic UDI-DI: B-06975132463334
Reference: FCG-101G-100
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463327
Basic UDI-DI: B-06975132463327
Reference: FCG-101G-10
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000004533
UDI-DI: 06975132463310
Basic UDI-DI: B-06975132463310
Reference: FCG-101G-1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:59

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POCBio Pregnancy(hCG) Rapid Test

LATW01-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093839
Basic UDI-DI: B-06974912093839
Reference: LATW01-C50
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Beta Subunit of Human Chorionic Gonadotropin (β-HCG) Detection Kit(Fluorescence Immunoassay)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891520
Basic UDI-DI: B-06974674891520
Reference: 18-02-0102
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

5 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565523
Basic UDI-DI: B-06974541565523
Reference: ICA2235
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

20 tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565400
Basic UDI-DI: B-06974541565400
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565394
Basic UDI-DI: B-06974541565394
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Hungary
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

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2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565387
Basic UDI-DI: B-06974541565387
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Pregnancy Test For Self testing

hCG Pregnancy Test For Self testing

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246460789
Basic UDI-DI: B-06974246460789
Reference: HCG-1011/HCG-1012/HCG-1013
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

MomMed Pregnancy Test

Srtiip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Co-Innovation Biotech Co., Ltd
Manufacturer SRN: CN-MF-000032023
UDI-DI: 06970429842014
Basic UDI-DI: B-06970429842014
Reference: HCG101-S
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

"Prueba Rápida de Embarazo (hCG) de Sensibilidad mejorada en Tira "

"Prueba Rápida de Embarazo (hCG) de Sensibilidad mejorada en Tira "

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126236
Basic UDI-DI: B-06936983126236
Reference: FHC-U201
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Graviditetstest med Ukeindikator

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500048041
Basic UDI-DI: 4084500CB985
Reference: 04084500048041
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 06.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Pregnancy Test with Weeks Indicator

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500477285
Basic UDI-DI: 4084500CB985
Reference: 04084500477285
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 06.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Pregnancy Test with Weeks Indicator

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500477360
Basic UDI-DI: 4084500CB985
Reference: 04084500477360
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 06.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Test di gravidanza con Indicatore delle Settimane

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500885561
Basic UDI-DI: 4084500CB985
Reference: 04084500885561
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 06.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details