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781 device results listed.

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FIA Go β-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936310
Basic UDI-DI: B-06971225936310
Reference: FIA20025
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo TB-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935849
Basic UDI-DI: B-06971225935849
Reference: KM09018
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo TB-HCG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225935832
Basic UDI-DI: B-06971225935832
Reference: KM09060
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go AMH Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931308
Basic UDI-DI: B-06971225931308
Reference: FIA30025
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

β-humanchorionic gonadotrophin

β-Human Chorionic Gonadotropin Quantitative Test Kit (Fluorescence Immunochromatography)

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-06934175046287QW
Basic UDI-DI: B-06934175046287QW
Reference: 12600785
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Self Clear

Self Clear MK

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 05206977000035
Basic UDI-DI: B-05206977000035
Reference: ACO-01-001M
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Greece
Authorised representative: -
Last updated: 06.07.2026 08:29

Manufacturer products View details

Estriol (CLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048017
Basic UDI-DI: 69449040004H-E3********T3
Reference: 105-004253-00
EMDN: W0102050202
EMDN description: ESTRIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Total β HCG Calibrators

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048314
Basic UDI-DI: 69449040004H-HCG-II****HG
Reference: 105-004290-00
EMDN: W0102050205
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estriol Calibrators

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048383
Basic UDI-DI: 69449040004H-E3********T3
Reference: 105-004297-00
EMDN: W0102050202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estrone ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030206
Basic UDI-DI: B-04049325030206
Reference: DB52051
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

Anti-Müllerian Hormone (AMH) ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325023031
Basic UDI-DI: B-04049325023031
Reference: 30150318
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

Estrone Saliva ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325009035
Basic UDI-DI: B-04049325009035
Reference: RE52681
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

PLGF ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325007710
Basic UDI-DI: B-04049325007710
Reference: RE52361
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:10

Manufacturer products View details

Lepzi PLGF Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Lepzi Diagnostika Ltd.
Manufacturer SRN: BG-MF-000051504
UDI-DI: 03800502152019
Basic UDI-DI: B-03800502152019
Reference: LD_BG002
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Bulgaria
Authorised representative: -
Last updated: 05.07.2026 22:36

Manufacturer products View details

RIA-gnost HCG

OCPM03-HCG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321418
Basic UDI-DI: B-03770024321418
Reference: OCPM03-HCG
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:32

Manufacturer products View details

03770024321166

ELSA-FBHCG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321166
Basic UDI-DI: B-03770024321166
Reference: ELSA-FBHCG
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

Toda Preterm Diag

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511153
Basic UDI-DI: B-03760309511153
Reference: 21GO1-1
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

Toda Preterm Diag 10

Toda Preterm Diag

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511146
Basic UDI-DI: B-03760309511146
Reference: 21GO1-10
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

Toda Preterm Diag 20

Toda Preterm Diag

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511139
Basic UDI-DI: B-03760309511139
Reference: 21GO1-20
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

Toda fFN Diag

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309510408
Basic UDI-DI: B-03760309510408
Reference: 1053-1
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details