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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

06973316742237

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742237
Basic UDI-DI: B-06973316742237
Reference: R331092
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

06973316742220

25 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742220
Basic UDI-DI: B-06973316742220
Reference: R331091
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

06973316742213

10 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742213
Basic UDI-DI: B-06973316742213
Reference: R331090
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

MomMed Ovulation Test

Strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Co-Innovation Biotech Co., Ltd
Manufacturer SRN: CN-MF-000032023
UDI-DI: 06970429844223
Basic UDI-DI: B-06970429844223
Reference: MomMed LH102-S
EMDN: W0102160304
EMDN description: LH - 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

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

06952804837051

Free Human Chorionic Gonadotropin Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804837051
Basic UDI-DI: B-06952804837051
Reference: G008A08X
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

06952804826185

Luteinizing Hormone Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804826185
Basic UDI-DI: B-06952804826185
Reference: G005A08X
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

"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

PreventID® Menopause

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013346
Basic UDI-DI: B-04050598013346
Reference: KST17114GP
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details