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D-3397E

Progesterone Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3397E
Basic UDI-DI: B-3397E
Reference: /
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-32675

Prolactin Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-32675
Basic UDI-DI: B-32675
Reference: /
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-3246Z

Follicle-stimulating Hormone Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3246Z
Basic UDI-DI: B-3246Z
Reference: /
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-3236X

Beta Human Chorionic Gonadotropin Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3236X
Basic UDI-DI: B-3236X
Reference: /
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-30409Y

Luteinizing Hormone in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-30409Y
Basic UDI-DI: B-30409Y
Reference: AKBR3040030
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-3038AD

Testosterone in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-3038AD
Basic UDI-DI: B-3038AD
Reference: AKBR3038030
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-3037AB

Prolactin in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-3037AB
Basic UDI-DI: B-3037AB
Reference: AKBR3037030
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-3019A9

Total βHCG in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-3019A9
Basic UDI-DI: B-3019A9
Reference: AKBR3019030
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-30129T

AMH in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-30129T
Basic UDI-DI: B-30129T
Reference: AKBR3012030
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Müllerian Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346205
Basic UDI-DI: B-20850076346205
Reference: CAAMH-301a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Total Beta-Human Chorionic Gonadotropin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346199
Basic UDI-DI: B-20850076346199
Reference: CAHCG-301a
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346182
Basic UDI-DI: B-20850076346182
Reference: CAPRO-301a
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346151
Basic UDI-DI: B-20850076346151
Reference: CAIPRL-301a
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346144
Basic UDI-DI: B-20850076346144
Reference: CATES-301a
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle Stimulating Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346175
Basic UDI-DI: B-20850076346175
Reference: CAFSH-301a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346168
Basic UDI-DI: B-20850076346168
Reference: CAE2-301a
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346137
Basic UDI-DI: B-20850076346137
Reference: CALH-301a
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Prolactin

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718772
Basic UDI-DI: 692591270014GU
Reference: C86013
EMDN: W0102050108
EMDN description: PROLACTIN
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

iFlash-E2

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718901
Basic UDI-DI: 692591270018H4
Reference: C86032
EMDN: W0102050103
EMDN description: ESTRADIOL
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

iFlash-Progesterone

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718918
Basic UDI-DI: 692591270016GY
Reference: C86030
EMDN: W0102050106
EMDN description: 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