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31.07.2026 22:52

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41 device results listed.

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17α-OHP CLIA Microparticles

AutoLumo Analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543668
Basic UDI-DI: 697015090000034GZ
Reference: CMF0903
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-17α-OH-P

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718048
Basic UDI-DI: 692591270154HD
Reference: C86061
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS 17-OH Progesterone

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690738
Basic UDI-DI: 5060169690738XP
Reference: IS-5100
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

RIA 17α-Hydroxyprogesterone

Immunoassay, IM1452

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214715
Basic UDI-DI: 150995905IM14525M
Reference: IM1452
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

D-A072D8

INDICAID® FSH Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A072D8
Basic UDI-DI: B-A072D8
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 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

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