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IMMULITE 2000 Estradiol

IVDR_67_LLB_DUB-C_C_REAG_KIT_Estradiol

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414966007
Basic UDI-DI: 0405686901449VU
Reference: 10381177
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnanediol-3-Glucuronide Test Kit (FIA)

VID75

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID753E
Basic UDI-DI: B-VID753E
Reference: VID75-05-011
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone Test Kit (FIA)

VID56

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID563A
Basic UDI-DI: B-VID563A
Reference: VID56-05-011
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone Test Kit (FIA)

VID55

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID5538
Basic UDI-DI: B-VID5538
Reference: VID55-05-011
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin Test Kit (FIA)

VID32

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID322U
Basic UDI-DI: B-VID322U
Reference: VID32-05-011
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle-stimulating Hormone Test Kit (FIA)

VID31

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID312S
Basic UDI-DI: B-VID312S
Reference: VID31-05-011
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinising Hormone Test Kit (FIA)

VID23

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID232T
Basic UDI-DI: B-VID232T
Reference: VID23-05-011
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aichek

TESTO Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Testo706-AE5N
Basic UDI-DI: B-Testo706-AE5N
Reference: Testo706-AE10Y, Testo706-AE10N, Testo706-AE20Y, Testo706-AE20N
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-0947

Prolactin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-0947
Basic UDI-DI: B-TD-HNKX-CED-0947
Reference: /
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-0845

Testosterone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-0845
Basic UDI-DI: B-TD-HNKX-CED-0845
Reference: /
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-0743

Progesterone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-0743
Basic UDI-DI: B-TD-HNKX-CED-0743
Reference: /
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-063Z

Estradiol Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-063Z
Basic UDI-DI: B-TD-HNKX-CED-063Z
Reference: /
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-053X

Luteinizing Hormone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-053X
Basic UDI-DI: B-TD-HNKX-CED-053X
Reference: /
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-043V

Follicle Stimulating Hormone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-043V
Basic UDI-DI: B-TD-HNKX-CED-043V
Reference: /
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Sex Hormone-Binding Globulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SHBG706-AE2D
Basic UDI-DI: B-SHBG706-AE2D
Reference: SHBG706-AE10Y, SHBG706-AE10N, SHBG706-AE20Y, SHBG706-AE20N
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

Prog Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Prog706-AEYF
Basic UDI-DI: B-Prog706-AEYF
Reference: Prog706-AE10Y, Prog706-AE10N, Prog706-AE20Y, Prog706-AE20N
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Prolactin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723469
Basic UDI-DI: 88001117IPBA01IA13VY
Reference: 16PRL10F
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Prolactin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723476
Basic UDI-DI: 88001117IPBA01IA13VY
Reference: 16PRL10Q
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724022

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724022
Basic UDI-DI: 88001117IPBA01IA14W2
Reference: 16E210F
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724039

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724039
Basic UDI-DI: 88001117IPBA01IA14W2
Reference: 16E210Q
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details