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FT Free Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FTesto706-AED3
Basic UDI-DI: B-FTesto706-AED3
Reference: FTesto706-AE10Y, FTesto706-AE10N, FTesto706-AE20Y, FTesto706-AE20N
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Follicle Stimulating Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FSH706-AEYS
Basic UDI-DI: B-FSH706-AEYS
Reference: FSH706-AE10Y, FSH706-AE10N, FSH706-AE20Y, FSH706-AE20N
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

TES Quantitative Test Kit (Time-Resolved FIA)

FKTES-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FKTES-402aHGH4
Basic UDI-DI: B-FKTES-402aHGH4
Reference: FKTES-402a
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

TES Quantitative Test Kit (Time-Resolved FIA)

FKTES-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKTES-402aCG
Basic UDI-DI: B-FKTES-402aCG
Reference: FKTES-402a
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Quantitative Test Kit (Time-Resolved FIA)

FKSHB-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FKSHB-402aHG89
Basic UDI-DI: B-FKSHB-402aHG89
Reference: FKSHB-402a
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Quantitative Test Kit (Time-Resolved FIA)

FKSHB-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKSHB-402a6K
Basic UDI-DI: B-FKSHB-402a6K
Reference: FKSHB-402a
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

LH Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-LH-402RK
Basic UDI-DI: B-FI-LH-402RK
Reference: FI-LH-402
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-FSH-402S7
Basic UDI-DI: B-FI-FSH-402S7
Reference: FI-FSH-402
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Test cassette

β-hCG Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-BHCG-402GM
Basic UDI-DI: B-FI-BHCG-402GM
Reference: FI-BHCG-402
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

PROG Quantitative Test Kit (Time-Resolved FIA)

FAPRO-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAPRO-402aHGAR
Basic UDI-DI: B-FAPRO-402aHGAR
Reference: FAPRO-402a
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROG Quantitative Test Kit (Time-Resolved FIA)

FAPRO-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAPRO-402a87
Basic UDI-DI: B-FAPRO-402a87
Reference: FAPRO-402a
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Quantitative Test Kit (Time-Resolved FIA)

FAPRL-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAPRL-402aHG8Y
Basic UDI-DI: B-FAPRL-402aHG8Y
Reference: FAPRL-402a
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Quantitative Test Kit (Time-Resolved FIA)

FAPRL-402a

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAPRL-402a6Y
Basic UDI-DI: B-FAPRL-402a6Y
Reference: FAPRL-402a
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Quantitative Test Kit (Time-Resolved FIA)

FAE2-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAE2-302aHGY2
Basic UDI-DI: B-FAE2-302aHGY2
Reference: FAE2-302a
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Quantitative Test Kit (Time-Resolved FIA)

FAE2-302a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAE2-302aHD
Basic UDI-DI: B-FAE2-302aHD
Reference: FAE2-302a
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Quantitative Test Kit (Time-Resolved FIA)

FAAMH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAAMH-402aRP
Basic UDI-DI: B-FAAMH-402aRP
Reference: FAAMH-402a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Quantitative Test Kit (Time-Resolved FIA)

FAAMH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAAMH-402aHGMB
Basic UDI-DI: B-FAAMH-402aHGMB
Reference: FAAMH-402a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Quantitative Test Kit (Time-Resolved FIA)

FAAMH-302a

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAAMH-302aRG
Basic UDI-DI: B-FAAMH-302aRG
Reference: FAAMH-302a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Quantitative Test Kit (Time-Resolved FIA)

FAAMH-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAAMH-302aHGLW
Basic UDI-DI: B-FAAMH-302aHGLW
Reference: FAAMH-302a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)

50T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0025Z8
Basic UDI-DI: B-FA0025Z8
Reference: 52027112
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details