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06974671101479

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101479
Basic UDI-DI: B-06974671101479
Reference: DR-HO-A011
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101424

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101424
Basic UDI-DI: B-06974671101424
Reference: DR-HO-A002
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 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101332

250 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101332
Basic UDI-DI: B-06974671101332
Reference: DR-CLIA-HO-B004
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101325

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101325
Basic UDI-DI: B-06974671101325
Reference: DR-CLIA-HO-A004
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Rapid Test

5Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303834
Basic UDI-DI: B-06974566303834
Reference: FHC-3025
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Rapid Test

50Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303827
Basic UDI-DI: B-06974566303827
Reference: FHC-30225
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303810
Basic UDI-DI: B-06974566303810
Reference: FHC-30225
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Finland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Rapid Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303803
Basic UDI-DI: B-06974566303803
Reference: FHC-30220
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Finland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Rapid Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303797
Basic UDI-DI: B-06974566303797
Reference: FHC-3021
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565516

1 Test/Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565516
Basic UDI-DI: B-06974541565516
Reference: ICA2235
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
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

06974541565370

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565370
Basic UDI-DI: B-06974541565370
Reference: ICA2225
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-Human Chorionic Gonadotropin (beta-hCG) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061776
Basic UDI-DI: B-06974524061776
Reference: HCLIA15118
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004578
Basic UDI-DI: B-06974521004578
Reference: SUPM058072
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004561
Basic UDI-DI: B-06974521004561
Reference: SUPM058036
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001027
Basic UDI-DI: B-06974521001027
Reference: SUPM080072
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001010
Basic UDI-DI: B-06974521001010
Reference: SUPM080036
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for β-HCG (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000778
Basic UDI-DI: B-06974521000778
Reference: SUPF020025
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Anti-Müllerian Hormone (AMH) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000488
Basic UDI-DI: B-06974521000488
Reference: SUPF030025
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Fibronectin Rapid Test Kit (Colloidal gold method)

YS010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308700
Basic UDI-DI: B-06974473308700
Reference: YS010
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591586
Basic UDI-DI: B-06974464591586
Reference: 5364C4X025
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details