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Estradiol assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7E03DS
Basic UDI-DI: B-7E03DS
Reference: 7E03V1-B-EU, 7E03U1-B-EU, 7E03P1-B-EU
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7E02DQ
Basic UDI-DI: B-7E02DQ
Reference: 7E02V1-B-EU, 7E02U1-B-EU, 7E02P1-B-EU
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7E01DN
Basic UDI-DI: B-7E01DN
Reference: 7E01V1-B-EU, 7E01U1-B-EU, 7E01P1-B-EU
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Müllerian Hormone assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D06DT
Basic UDI-DI: B-7D06DT
Reference: 7D06V1-B-EU, 7D06U1-B-EU, 7D06P1-B-EU
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D04DP
Basic UDI-DI: B-7D04DP
Reference: 7D04V1-B-EU, 7D04U1-B-EU, 7D04P1-B-EU
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin (PRL) assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D03DM
Basic UDI-DI: B-7D03DM
Reference: 7D03V1-B-EU, 7D03U1-B-EU, 7D03P1-B-EU
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D02DK
Basic UDI-DI: B-7D02DK
Reference: 7D02V1-B-EU, 7D02U1-B-EU, 7D02P1-B-EU
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle-Stimulating Hormone assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D01DH
Basic UDI-DI: B-7D01DH
Reference: 7D01V1-B-EU, 7D01U1-B-EU, 7D01P1-B-EU
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

17 α-OHP (eCLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075715
Basic UDI-DI: 69703416803205116JF
Reference: 0320514601
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

17 α-OHP (eCLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075708
Basic UDI-DI: 69703416803205116JF
Reference: 0320514602
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

17 α-OHP (eCLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075692
Basic UDI-DI: 69703416803205116JF
Reference: 0320514603
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol II (Electrochemiluminescence Immunoassay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139074206
Basic UDI-DI: 69703416803205117JH
Reference: 697131
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol II (Electrochemiluminescence Immunoassay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139074220
Basic UDI-DI: 69703416803205117JH
Reference: 697132
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol II (Electrochemiluminescence Immunoassay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139074213
Basic UDI-DI: 69703416803205117JH
Reference: 697134
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

free TESTO (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075128
Basic UDI-DI: 69703416803205076JU
Reference: 0320514701
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

free TESTO (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075104
Basic UDI-DI: 69703416803205076JU
Reference: 0320514703
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

free TESTO (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075111
Basic UDI-DI: 69703416803205076JU
Reference: 0320514704
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Suretest Precoce

Suretest Precoce Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: D-361481999602668
Basic UDI-DI: B-361481999602668
Reference: TNG25A-12E
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 11.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-3416Z

Estradiol Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3416Z
Basic UDI-DI: B-3416Z
Reference: /
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-3406X

Testosterone Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3406X
Basic UDI-DI: B-3406X
Reference: /
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details