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847 device results listed.

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β-HCG Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807177094RC
Basic UDI-DI: B-000012807177094RC
Reference: HWTS-PF009
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone 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: 06978465235470
Basic UDI-DI: 697846523HormoneB10HQ
Reference: 2×100 test
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:35

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

Pylon AMH

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025453
Basic UDI-DI: 697648502AMHUB
Reference: 10-2227 40 tests/kit
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon β-HCG

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485022933
Basic UDI-DI: 697648502HCGUE
Reference: 10-2117 40 tests/kit
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

β-Human Chorionic Gonadotropin Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500096
Basic UDI-DI: 697518250P117076T
Reference: P11710
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ BETA-HCG

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404991
Basic UDI-DI: 697139043040988
Reference: 010409001
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
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

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

AMH CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577171900
Basic UDI-DI: 697015090000047HA
Reference: CMS0501
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AMH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716401808
Basic UDI-DI: 693971640412LJ
Reference: 010412401
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

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

Multichem AMH

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523441193
Basic UDI-DI: 539152344IMMA069L
Reference: AM500A
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 03:14

Manufacturer products 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

Estriol high sensitive Saliva ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030527
Basic UDI-DI: 4049325IVR06080009BU7
Reference: 30121046
EMDN: W0102050202
EMDN description: ESTRIOL
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

AMH Gen II ELISA KIT

Immunoassay, D00324

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590787486
Basic UDI-DI: 150995905D00324RC
Reference: D00324
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 01.07.2026 12:00

Manufacturer products View details

Access AMH Advanced (Reagent Pack)

C62997

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590740481
Basic UDI-DI: 150995903AccAMHAdFB
Reference: C629997
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 11:50

Manufacturer products View details

Access AMH Reagent Pack

B13127

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590669263
Basic UDI-DI: 150995903AccAMHN5
Reference: B13127
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 11:49

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

Access Unconjugated Estriol (Reagent Pack)

C22255

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590702120
Basic UDI-DI: 150995901AccEstriol56
Reference: C22255
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
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

HOKAPI™ BETA-HCG

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439869
Basic UDI-DI: 697139043040988
Reference: 010409101
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details