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D-OVULATIONTEST3K

Ovulation Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: Sanavita Pharmaceuticals GmbH
Manufacturer SRN: DE-MF-000005463
UDI-DI: D-OVULATIONTEST3K
Basic UDI-DI: B-OVULATIONTEST3K
Reference: OVULATIONTEST
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: -
Last updated: 14.07.2026 06:15

Manufacturer products View details

ClinMass®

MS12000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS12000P6
Basic UDI-DI: B-MS12000P6
Reference: MS12000
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

LH Luteinizing Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-LH706-AE47
Basic UDI-DI: B-LH706-AE47
Reference: LH706-AE10Y, LH706-AE10N, LH706-AE20Y, LH706-AE20N
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX Testo CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-Testo-01100CJY
Basic UDI-DI: B-KR-Testo-01100CJY
Reference: KR-Testo-01100C
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX Prog CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-Prog-01100CRF
Basic UDI-DI: B-KR-Prog-01100CRF
Reference: KR-Prog-01100C
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PRL CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PRL-01100CBV
Basic UDI-DI: B-KR-PRL-01100CBV
Reference: KR-PRL-01100C
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX LH CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-LH-01100CEZ
Basic UDI-DI: B-KR-LH-01100CEZ
Reference: KR-LH-01100C
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX FSH CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-FSH-01100CZ3
Basic UDI-DI: B-KR-FSH-01100CZ3
Reference: KR-FSH-01100C
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX E2 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-E2-01100CVE
Basic UDI-DI: B-KR-E2-01100CVE
Reference: KR-E2-01100C
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-045PK

Sex hormone binding globulin (SHBG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-045PK
Basic UDI-DI: B-K90411-045PK
Reference: /
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-038PN

Follicle stimulating hormone (FSH) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-038PN
Basic UDI-DI: B-K90411-038PN
Reference: /
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-036PJ

Luteinizing hormone (LH) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-036PJ
Basic UDI-DI: B-K90411-036PJ
Reference: /
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-025PD

Prolactin (PRL) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-025PD
Basic UDI-DI: B-K90411-025PD
Reference: /
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-021P5

Estradiol (E2) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-021P5
Basic UDI-DI: B-K90411-021P5
Reference: /
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-019PJ

Testosterone (TESTO) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-019PJ
Basic UDI-DI: B-K90411-019PJ
Reference: /
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck SHBG

20 tests/ kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K42-SHBGYR
Basic UDI-DI: B-K42-SHBGYR
Reference: 811023/K42-SHBG
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-K01220VY

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-K01220VY
Basic UDI-DI: B-K01220VY
Reference: K01220
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Austria
Authorised representative: -
Last updated: 14.07.2026 03:35

Manufacturer products View details

D-K00234W4

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-K00234W4
Basic UDI-DI: B-K00234W4
Reference: K00234
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Austria
Authorised representative: -
Last updated: 14.07.2026 03:35

Manufacturer products View details

D-K00225W3

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-K00225W3
Basic UDI-DI: B-K00225W3
Reference: K00225
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Austria
Authorised representative: -
Last updated: 14.07.2026 03:35

Manufacturer products View details

D-K00203VR

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-K00203VR
Basic UDI-DI: B-K00203VR
Reference: K00203
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Austria
Authorised representative: -
Last updated: 14.07.2026 03:35

Manufacturer products View details