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HCG+β Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414736878
Basic UDI-DI: B-06954414736878
Reference: IF8013
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 17:53

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414723793
Basic UDI-DI: B-06954414723793
Reference: IF8066
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 17:52

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Müllerian Hormone (AMH) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061783
Basic UDI-DI: B-06974524061783
Reference: HCLIA15117
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

Soluble Fms-Iike Tyrosine Kinase-1 (sFlt-1) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524062216
Basic UDI-DI: B-06974524062216
Reference: HCLIA15135
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS 17-OH Progesterone

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690738
Basic UDI-DI: 5060169690738XP
Reference: IS-5100
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 12.08.2026 02:47

Manufacturer products Authorised representative products Authorised representative actors View details

Total β Human Chorionic Gonadotrophin（CLIA）

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415981242
Basic UDI-DI: 69449040004H-HCG-II****HG
Reference: 105-017089-00
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.08.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Total β Human Chorionic Gonadotrophin（CLIA）

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415981259
Basic UDI-DI: 69449040004H-HCG-II****HG
Reference: 105-017090-00
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.08.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Placental Growth Factor (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858212
Basic UDI-DI: B-06933289858212
Reference: W495P0003
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Placental Growth Factor (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858205
Basic UDI-DI: B-06933289858205
Reference: W495P0002
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Placental Growth Factor (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858236
Basic UDI-DI: B-06933289858236
Reference: W495P0005
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Placental Growth Factor (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858229
Basic UDI-DI: B-06933289858229
Reference: W495P0004
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

08809408862829

Surearly SMART Ovulation Hormone Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862829
Basic UDI-DI: 88094088SLHR-001AC
Reference: SLHR003E
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 08.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone (Electrochemiluminescence Immunoassay)

100T