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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

ADVIA Centaur Total hCG

IVDR_67_TTN_DUB-C_C_KIT_ThCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414505152
Basic UDI-DI: 0405686901823VW
Reference: 10308984
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Placental Growth Factor (PlGF)

IVDR_67_LLB_DUB-C_C_REAG_Placental Growth Factor

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414290355
Basic UDI-DI: 0405686902128VC
Reference: 11200232
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Soluble fms-like Tyrosine Kinase-1 (sFlt-1)

IVDR_67_LLB_DUB-C_C_REAG_Soluble fms-like Tyrosine Kinase-1

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414015583
Basic UDI-DI: 0405686902122UY
Reference: 10997829
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Unconjugated Estriol

IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414971698
Basic UDI-DI: 0405686901473VR
Reference: 10381171
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
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

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

IMMULITE 2000 PAPP-A

IVDR_67_LLB_DUB-C_C_KIT_PAPP-A

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961835
Basic UDI-DI: 0405686901458VV
Reference: 10381213
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Free Beta HCG

IVDR_67_LLB_DUB-C_C_KIT_Free Beta HCG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961446
Basic UDI-DI: 0405686901450VD
Reference: 10381175
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-Z033204R

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z033204R
Basic UDI-DI: B-Z033204R
Reference: Z03320
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 14:12

Manufacturer products View details

Pregnanediol-3-Glucuronide Test Kit (FIA)

VID75