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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

Total β-HCG Total β-Human Chorionic Gonadotropin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TB-HCG706-AEN4
Basic UDI-DI: B-TB-HCG706-AEN4
Reference: TB-HCG706-AE10Y, TB-HCG706-AE10N, TB-HCG706-AE20Y, TB-HCG706-AE20N
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i β-hCG

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724176
Basic UDI-DI: 88001117IPBA01IA15W4
Reference: 16BHC10F
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

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

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022033ED
Basic UDI-DI: B-SAC2022033ED
Reference: SAC2022033
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022032EB
Basic UDI-DI: B-SAC2022032EB
Reference: SAC2022032
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022031E9
Basic UDI-DI: B-SAC2022031E9
Reference: SAC2022031
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products 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

STANDARD™ i Testosterone

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724084
Basic UDI-DI: 88001117IPBA01IA34W8
Reference: 16TES10F
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Testosterone

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724091
Basic UDI-DI: 88001117IPBA01IA34W8
Reference: 16TES10Q
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Total hCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414505176
Basic UDI-DI: 0405686901823VW
Reference: 10308985
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Prolactin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PRL706-AE9L
Basic UDI-DI: B-PRL706-AE9L
Reference: PRL706-AE10Y, PRL706-AE10N, PRL706-AE20Y, PRL706-AE20N
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-PREGNANCYTESTBQ

Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: Sanavita Pharmaceuticals GmbH
Manufacturer SRN: DE-MF-000005463
UDI-DI: D-PREGNANCYTESTBQ
Basic UDI-DI: B-PREGNANCYTESTBQ
Reference: PREGNANCYTEST
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 17:12

Manufacturer products View details

PDG One Step Ovulation Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PDG-A01aC7
Basic UDI-DI: B-PDG-A01aC7
Reference: PDG-A01a
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-OVULATIONTEST3K

Ovulation Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: Sanavita Pharmaceuticals GmbH
Manufacturer SRN: DE-MF-000005463
UDI-DI: D-OVULATIONTEST3K
Basic UDI-DI: B-OVULATIONTEST3K
Reference: OVULATIONTEST
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: -
Last updated: 14.07.2026 06:15

Manufacturer products View details

ClinMass®

MS12000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS12000P6
Basic UDI-DI: B-MS12000P6
Reference: MS12000
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details