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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

06974541565523

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

06974541565486

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565486
Basic UDI-DI: B-06974541565486
Reference: ICA2230
EMDN: W0102160304
EMDN description: LH - 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

06974541565479

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565479
Basic UDI-DI: B-06974541565479
Reference: ICA2230
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Slovakia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565462

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565462
Basic UDI-DI: B-06974541565462
Reference: ICA2230
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Slovakia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565448

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565448
Basic UDI-DI: B-06974541565448
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
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

06974541565431

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565431
Basic UDI-DI: B-06974541565431
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Ireland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565424

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565424
Basic UDI-DI: B-06974541565424
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Poland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565400

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

06974541565394

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

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565387

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

Progesterone (PROG) Rapid Quantitative Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521002277
Basic UDI-DI: B-06974521002277
Reference: SUPF123024
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

Follicle Stimulating Hormone Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841001144
Basic UDI-DI: B-06973841001144
Reference: BA0380
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone Test Kit (Immunofluorescence)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841001137
Basic UDI-DI: B-06973841001137
Reference: BA0300
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742343

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742343
Basic UDI-DI: B-06973316742343
Reference: R331083
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742336

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742336
Basic UDI-DI: B-06973316742336
Reference: R331082
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742329

25 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742329
Basic UDI-DI: B-06973316742329
Reference: R331081
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742312

10 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742312
Basic UDI-DI: B-06973316742312
Reference: R331080
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742244

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742244
Basic UDI-DI: B-06973316742244
Reference: R331093
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details