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135 device results listed.

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Pregnancy (hCG) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910285
Basic UDI-DI: B-06974238910285
Reference: HHCG001
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 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

06973861683962

β-HCG Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683962
Basic UDI-DI: B-06973861683962
Reference: A02025002
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Rapid Test Device

G071216T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053038
Basic UDI-DI: B-06971792053038
Reference: G071216T
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin (HCG) Assay Reagent Kit (CMIA)

C2KC005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051614
Basic UDI-DI: B-06971792051614
Reference: C2KC005
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

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

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

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

BIOSYNEX HCG 10 BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678593944
Basic UDI-DI: B-03532678593944
Reference: SW10003
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin beta subunit Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465234770
Basic UDI-DI: 697846523HormoneB12HU
Reference: 2×100 test
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HCG

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404977
Basic UDI-DI: 697139043040886
Reference: 010408001
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605356

Total β- Human Chorionic Gonadotropin (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605356
Basic UDI-DI: 69268026MD761F0000000013C
Reference: MCL05801E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

hey mela Schwangerschaftstest

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesSelf testing

Manufacturer: VELLAP Diagnostics GmbH
Manufacturer SRN: DE-MF-000035636
UDI-DI: 04260743470737
Basic UDI-DI: 426074347.2.13.1.704.5G
Reference: 2.13.1.715
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:09

Manufacturer products View details

Access Total βhCG (Reagent Pack)

C28645

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590744380
Basic UDI-DI: 150995901A9000TBhCGLA
Reference: C28645
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522641651
Basic UDI-DI: B-06970522641651
Reference: CL1703
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:45

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605363

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605363
Basic UDI-DI: 69268026MD761F0000000013C
Reference: MCL05802E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 29.06.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605370

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605370
Basic UDI-DI: 69268026MD761F0000000013C
Reference: MCL05803E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 29.06.2026 22:59

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: 06903053157896
Basic UDI-DI: 69449040004H-HCG-II****HG
Reference: 105-064646-00
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU)

Format(Strip):A02600150, A02600250;Format(Device):A03010125, A03010140, A03010225, A03010240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804833459
Basic UDI-DI: 69528048A030100WF
Reference: Format(Strip):A02600;Format(Device):A03010
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Test (Colloidal Gold)

Cassette Strip Midstream

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062779247
Basic UDI-DI: B-06952062779247
Reference: HCG3UST -100
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 28.06.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details