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758 device results listed.

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β-HCG Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763594
Basic UDI-DI: B-15065023763594
Reference: TV20021
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

14562185400417

CL AIA-PACK βHCG ADJUSTER SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400417
Basic UDI-DI: B-14562185400417
Reference: 0029228
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

14562185400325

CL AIA-PACK βHCG TEST CUP

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400325
Basic UDI-DI: B-14562185400325
Reference: 0029128
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

14562185399704

CL AIA-PACK HCG ADJUSTER SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185399704
Basic UDI-DI: B-14562185399704
Reference: 0029223
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

14562185399698

CL AIA-PACK HCG TEST CUP

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185399698
Basic UDI-DI: B-14562185399698
Reference: 0029123
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

14560189212418

ST AIA-PACK βHCGII

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189212418
Basic UDI-DI: B-14560189212418
Reference: 0025220
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

14560189212371

ST AIA-PACK HCGII

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189212371
Basic UDI-DI: B-14560189212371
Reference: 0025219
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

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: 10850076346208
Basic UDI-DI: B-10850076346208
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 04:37

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: 10850076346192
Basic UDI-DI: B-10850076346192
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 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

RAMP Total b-hCG

RAMP Total b-hCG (C1117)

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Response Biomedical Corp.
Manufacturer SRN: CA-MF-000034747
UDI-DI: 10627966005275
Basic UDI-DI: B-10627966005275
Reference: C1117
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Total hCG (ThCG)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600024
Basic UDI-DI: 0405686901823VW
Reference: 10995689
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Total hCG (ThCG)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600031
Basic UDI-DI: 0405686901823VW
Reference: 10995690
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG STAT

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064185
Basic UDI-DI: 69703416803205099K8
Reference: 0320509302
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG STAT

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064192
Basic UDI-DI: 69703416803205099K8
Reference: 0320509303
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG STAT

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064208
Basic UDI-DI: 69703416803205099K8
Reference: 0320509304
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Unconjugated Estriol

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414997162
Basic UDI-DI: 0405686901473VR
Reference: 10381192
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

08800026300106

Exdia β-hCG

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Precision Biosensor Inc.
Manufacturer SRN: KR-MF-000034861
UDI-DI: 08800026300106
Basic UDI-DI: B-08800026300106
Reference: PR-FC10
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 09.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ AMH Rapid Test Kit (FIA)

VMPO42

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250803
Basic UDI-DI: B-08683548250803
Reference: VMPO42
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

RapidFor™ β-HCG (FIA)

VMPO15EP

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250261
Basic UDI-DI: B-08683548250261
Reference: VMPO15
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

EUROSPITAL - TEST DI GRAVIDANZA IN AUTODIAGNOSI

EUROSPITAL - TEST DI GRAVIDANZA

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Logiter One Srl
Manufacturer SRN: IT-MF-000037076
UDI-DI: 08050593875211
Basic UDI-DI: B-08050593875211
Reference: TGLOG-14
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details