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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

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

Testosterone (Testo) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0024Z6
Basic UDI-DI: B-FA0024Z6
Reference: 52027110
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone (Prog) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0023Z4
Basic UDI-DI: B-FA0023Z4
Reference: 52027109
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin (PRL) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0022Z2
Basic UDI-DI: B-FA0022Z2
Reference: 52027108
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206009FJ

Testosterone

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206009FJ
Basic UDI-DI: B-EIM4206009FJ
Reference: EIM4206009
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206006FC

Progesterone

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206006FC
Basic UDI-DI: B-EIM4206006FC
Reference: EIM4206006
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206005FA

PRL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206005FA
Basic UDI-DI: B-EIM4206005FA
Reference: EIM4206005
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206004F8

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206004F8
Basic UDI-DI: B-EIM4206004F8
Reference: EIM4206004
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206003F6

FSH

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206003F6
Basic UDI-DI: B-EIM4206003F6
Reference: EIM4206003
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details