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LIAISON® LH

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200134
Basic UDI-DI: B-08056771200134
Reference: 312201
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 22:32

Manufacturer products View details

PdG (Pregnanediol-3-Glucuronide) Rapid Test (Urine)

WPdG-4011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750617
Basic UDI-DI: B-06974785750617
Reference: WPdG-4011
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

Androstenedione Saliva

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDSNOV270_
Basic UDI-DI: B-+ENTIDSNOV270_
Reference: DSNOV27
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

Prolactin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV03206
Basic UDI-DI: B-+ENTIDNOV03206
Reference: DNOV032
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

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FSH

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV03105
Basic UDI-DI: B-+ENTIDNOV03105
Reference: DNOV031
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

LH

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV03004
Basic UDI-DI: B-+ENTIDNOV03004
Reference: DNOV030
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

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Free Testosterone

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV0090A
Basic UDI-DI: B-+ENTIDNOV0090A
Reference: DNOV009
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

Androstenedione

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00809
Basic UDI-DI: B-+ENTIDNOV00809
Reference: DNOV008
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

Progesterone

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00607
Basic UDI-DI: B-+ENTIDNOV00607
Reference: DNOV006
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

DHEA-S

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00506
Basic UDI-DI: B-+ENTIDNOV00506
Reference: DNOV005
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

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17-OH Progesterone

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00405
Basic UDI-DI: B-+ENTIDNOV00405
Reference: DNOV004
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

17 beta-Estradiol

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00304
Basic UDI-DI: B-+ENTIDNOV00304
Reference: DNOV003
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

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Testosterone

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00203
Basic UDI-DI: B-+ENTIDNOV00203
Reference: DNOV002
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

EZFRPD-01 EZFRPD-02 EZFRPD-03 EZFRPD-04

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006684
Basic UDI-DI: 8905459HCGRTSF8Q
Reference: EZFRPD-01 EZFRPD-02 EZFRPD-03 EZFRPD-04
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Testosterone

i-TET-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724077
Basic UDI-DI: 88001117IPBA01IA34W8
Reference: 16TES10D
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

i-E2-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724015
Basic UDI-DI: 88001117IPBA01IA14W2
Reference: 16E210D
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Prolactin

i-PRL-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723452
Basic UDI-DI: 88001117IPBA01IA13VY
Reference: 16PRL10D
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

17 α-OHP (eCLIA)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075678
Basic UDI-DI: 69703416803205116JF
Reference: 0320514604
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol II (Electrochemiluminescence Immunoassay)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139074190
Basic UDI-DI: 69703416803205117JH
Reference: 697133
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (CLIA)

105-037228-00、105-037229-00

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157605
Basic UDI-DI: 69449040AB74000385V
Reference: 105-064656-00
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: 16.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details