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Free β-hCG AccuBind ELISA Kit - 192 wells

2025-300B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020587
Basic UDI-DI: B-00816870020587
Reference: 2025-300B
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

Free β-hCG AccuBind ELISA Kit - 96 wells

2025-300A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020570
Basic UDI-DI: B-00816870020570
Reference: 2025-300A
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

00816467020112

FastPack hCG Diluent Kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020112
Basic UDI-DI: B-00816467020112
Reference: 25000036
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

VMPO15EP

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250261
Basic UDI-DI: 868354825VMPO15EPNU
Reference: VMPO15EP
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:29

Manufacturer products View details

RapidFor™

VMPO38

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250490
Basic UDI-DI: 868354825VMPO38EPPR
Reference: VMPO38EP
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:29

Manufacturer products View details

RapidFor™

VMPO39

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250506
Basic UDI-DI: 868354825VMPO39EPPW
Reference: VMPO39EP
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:29

Manufacturer products View details

RapidFor™

VMPO42

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250803
Basic UDI-DI: 868354825VMPO42EPP2
Reference: VMPO42EP
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:26

Manufacturer products View details

STANDARD™ i SHBG

i-SHB-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111726439
Basic UDI-DI: 88001117IPBA01IA35WA
Reference: 16SHB10D
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

06973864380042

IVD Class BIVDR 2017/746No longer on the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864380042
Basic UDI-DI: 6978364380004FA
Reference: 05010301342
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

06973864380028

IVD Class BIVDR 2017/746No longer on the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864380028
Basic UDI-DI: 6978364380004FA
Reference: 05010301372
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

06973864380035

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864380035
Basic UDI-DI: 6978364380004FA
Reference: 05010301332
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

06973864380011

2 × 50 Tests; 2 × 100 Tests; 4 × 50 Tests; 4 × 100 Tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864380011
Basic UDI-DI: 6978364380004FA
Reference: 05010301322
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i SHBG

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111726446
Basic UDI-DI: 88001117IPBA01IA35WA
Reference: 16SHB10F
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:05

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i SHBG

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111726453
Basic UDI-DI: 88001117IPBA01IA35WA
Reference: 16SHB10Q
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:05

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone (Prog) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Progesterone (Prog)Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061738
Basic UDI-DI: B-06974524061738
Reference: HCLIA15111
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Free β-hCG AccuLite CLIA Kit - 192 wells

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022260
Basic UDI-DI: B-00816870022260
Reference: 2075-300B
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

Free β-hCG AccuLite CLIA Kit - 96 wells

2075-300A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022253
Basic UDI-DI: B-00816870022253
Reference: 2075-300A
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

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