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19.09.2026 08:46

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56 device results listed.

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INDICAID™ FSH Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A034CY
Basic UDI-DI: B-A034CY
Reference: INDICAID™ FSH Rapid Test
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIDNOV00405

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 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

D-K00192WD

N/A

IVD generalIVDDOn the marketAnimal tissuesHuman 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-K00192WD
Basic UDI-DI: B-K00192WD
Reference: K00192
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Austria
Authorised representative: -
Last updated: 14.07.2026 03:35

Manufacturer products View details

iStar-17α-OH-P

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76519G9
Basic UDI-DI: B-DC76519G9
Reference: DC76519
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-17α-OH-P

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76518G7
Basic UDI-DI: B-DC76518G7
Reference: DC76518
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-17α-OH-P

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76517G5
Basic UDI-DI: B-DC76517G5
Reference: DC76517
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-17α-OH-P

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76516G3
Basic UDI-DI: B-DC76516G3
Reference: DC76516
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:16

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

iFlash-17α-OH-P

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721130
Basic UDI-DI: 692591270154HD
Reference: C86061-S
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

17α-OHP CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543682
Basic UDI-DI: 697015090000034GZ
Reference: CMF0905
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay 17α-OHP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070768805
Basic UDI-DI: B-06975070768805
Reference: 14000832
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay 17α-OHP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070766078
Basic UDI-DI: B-06975070766078
Reference: 14000394
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoassay)

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986815122
Basic UDI-DI: B-06974986815122
Reference: 100 Tests/Kit
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoassay)

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986815115
Basic UDI-DI: B-06974986815115
Reference: 50 Tests/Kit
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

17-Alpha-Hydoxy Progesterone (17Alpha-OHP) Assay Kit (Chemiluminescent Immunoassay)

25 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986815108
Basic UDI-DI: B-06974986815108
Reference: 25 Tests/Kit
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

17α-Hydroxyprogesterone Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892855
Basic UDI-DI: B-06974674892855
Reference: 18-02-0157
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:17

Manufacturer products Authorised representative products Authorised representative actors View details

06972719601301

Reagents (include Calibrator and Control): 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719601301
Basic UDI-DI: B-06972719601301
Reference: 215E90001
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:36

Manufacturer products Authorised representative products Authorised representative actors View details