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Luteinizing Hormone Detection Kit (Chemiluminescence Immunoassay)

2×50Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224126
Basic UDI-DI: B-06942202224126
Reference: 3013873
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Detection Kit (Chemiluminescence Immunoassay)

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224119
Basic UDI-DI: B-06942202224119
Reference: 3013802
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone Detection Kit (Chemiluminescence Immunoassay)

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224102
Basic UDI-DI: B-06942202224102
Reference: 3013916
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay)

2×50Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224096
Basic UDI-DI: B-06942202224096
Reference: 3013785
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin Detection Kit (Chemiluminescence Immunoassay)

2×50Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224089
Basic UDI-DI: B-06942202224089
Reference: 3013733
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy HCG test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06940792402726
Basic UDI-DI: B-06940792402726
Reference: 2018240024503
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy HCG test

midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06940792402719
Basic UDI-DI: B-06940792402719
Reference: 2018240024503
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy HCG test

Cassette

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06940792402702
Basic UDI-DI: B-06940792402702
Reference: 2018240024502
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy HCG test

Strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06940792402696
Basic UDI-DI: B-06940792402696
Reference: 2018240024501
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation LH test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06940792402689
Basic UDI-DI: B-06940792402689
Reference: 20182400244003
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy HCG test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06940792402672
Basic UDI-DI: B-06940792402672
Reference: 2018240024504
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

17α-OH Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289860659
Basic UDI-DI: B-06933289860659
Reference: WZB3P0004
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

17α-OH Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289860642
Basic UDI-DI: B-06933289860642
Reference: WZB3P0003
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

17α-OH Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289860635
Basic UDI-DI: B-06933289860635
Reference: WZB3P0002
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

17α-OH Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289860628
Basic UDI-DI: B-06933289860628
Reference: WZB3P0001
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214389
Basic UDI-DI: B-06933260214389
Reference: CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck PRL Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214341
Basic UDI-DI: B-06933260214341
Reference: BT2207-PRL
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck TES Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214334
Basic UDI-DI: B-06933260214334
Reference: BT2211-TES
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214303
Basic UDI-DI: B-06933260214303
Reference: BT2212-E2
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802568

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802568
Basic UDI-DI: B-06930317802568
Reference: DNK-1901-41
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details