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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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743 device results listed.

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iFlash-Inhibin A

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723653
Basic UDI-DI: 692591270079HQ
Reference: C86044-S
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-free βhCG

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723660
Basic UDI-DI: 692591270080H9
Reference: C86050-S
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Unconjugated Estriol

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723684
Basic UDI-DI: 692591270078HN
Reference: C86043-S
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PAPP-A

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723929
Basic UDI-DI: 692591270077HL
Reference: C86042-S
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Rapid Quantitative Test

20 boxes/carton

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 16977565581446
Basic UDI-DI: B-16977565581446
Reference: 1442
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 10:10

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

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