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ADVIA Centaur Enhanced Estradiol

IVDR_67_TTN_DUB-C_C_KIT_eE2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414573342
Basic UDI-DI: 0405686901810VM
Reference: 10490889
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Enhanced Estradiol (eE2)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598857
Basic UDI-DI: 0405686901810VM
Reference: 10995561
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Enhanced Estradiol

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414574646
Basic UDI-DI: 0405686901810VM
Reference: 10491445
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Enhanced Estradiol (eE2)

IVDR_67_TTN_DUB-C_C_KIT_eE2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598864
Basic UDI-DI: 0405686901810VM
Reference: 10995562
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-DHEA-S

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76335FV
Basic UDI-DI: B-DC76335FV
Reference: DC76334
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-DHEA-S

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76334FT
Basic UDI-DI: B-DC76334FT
Reference: DC76334
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-DHEA-S

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76333FR
Basic UDI-DI: B-DC76333FR
Reference: DC76333
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-SHBG

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76332FP
Basic UDI-DI: B-DC76332FP
Reference: DC76332
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-SHBG

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76331FM
Basic UDI-DI: B-DC76331FM
Reference: DC76331
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-SHBG

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76330FK
Basic UDI-DI: B-DC76330FK
Reference: DC76330
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-DHEA-S

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76028FH
Basic UDI-DI: B-DC76028FH
Reference: DC76028
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:58

Manufacturer products Authorised representative products Authorised representative actors View details

LH Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-LHUC
Basic UDI-DI: B-CI-LHUC
Reference: CI-LH
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-FSH9L
Basic UDI-DI: B-CI-FSH9L
Reference: CI-FSH
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors 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

D-697994388Ir00332B6

Follicle Stimulating Hormone (FSH) Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir00332B6
Basic UDI-DI: B-697994388Ir00332B6
Reference: Ir003
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0022YDA

Luteinising Hormone (LH) Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0022YDA
Basic UDI-DI: B-697994388Ir0022YDA
Reference: Ir002
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation One Step Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303018
Basic UDI-DI: B-69743840303018
Reference: 3010401
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

FSH-U21(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712010928L
Basic UDI-DI: B-69717712010928L
Reference: FSH-U21(25PCS)
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

LH-U11(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712010858P
Basic UDI-DI: B-69717712010858P
Reference: LH-U11(25PCS)
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details