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855 device results listed.

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iStar-HCG

30 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76007F9
Basic UDI-DI: B-DC76007F9
Reference: DC76007
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349YS002PY
Basic UDI-DI: B-CNMF000054349YS002PY
Reference: YS002
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Anti-Müllerian Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-AMH706-AERM
Basic UDI-DI: B-AMH706-AERM
Reference: AMH706-AE10Y, AMH706-AE10N, AMH706-AE20Y, AMH706-AE20N
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

AL-196

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1963A
Basic UDI-DI: B-AL-1963A
Reference: AL-196
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-195-I - US Inhibin B ELISA (CE)

AL-195

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-19538
Basic UDI-DI: B-AL-19538
Reference: AL-195
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-138-I - Estriol EIA (CE)

AL-138

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1382U
Basic UDI-DI: B-AL-1382U
Reference: AL-138
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-129-I - DBS AMH ELISA

AL-129

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1292T
Basic UDI-DI: B-AL-1292T
Reference: AL-129
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-124-I - picoAMH ELISA

AL-124

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1242H
Basic UDI-DI: B-AL-1242H
Reference: AL-124
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-123-I - Inhibin B ELISA

AL-123

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1232F
Basic UDI-DI: B-AL-1232F
Reference: AL-123
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-11026
Basic UDI-DI: B-AL-11026
Reference: AL-110-I - Activin A ELISA
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-109

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1092M
Basic UDI-DI: B-AL-1092M
Reference: AL-109-I - PAPP-A2 ELISA
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-107-I - Inhibin B ELISA

AL-107

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1072H
Basic UDI-DI: B-AL-1072H
Reference: AL-107
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AL-1008 PLGF ELISA

AL-1008

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1008CU
Basic UDI-DI: B-AL-1008CU
Reference: AL-1008
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Müllerian Hormone assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D06DT
Basic UDI-DI: B-7D06DT
Reference: 7D06V1-B-EU, 7D06U1-B-EU, 7D06P1-B-EU
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7D04DP
Basic UDI-DI: B-7D04DP
Reference: 7D04V1-B-EU, 7D04U1-B-EU, 7D04P1-B-EU
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Suretest Precoce

Suretest Precoce Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: D-361481999602668
Basic UDI-DI: B-361481999602668
Reference: TNG25A-12E
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 11.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-3236X

Beta Human Chorionic Gonadotropin Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3236X
Basic UDI-DI: B-3236X
Reference: /
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-3019A9

Total βHCG in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-3019A9
Basic UDI-DI: B-3019A9
Reference: AKBR3019030
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-30129T

AMH in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-30129T
Basic UDI-DI: B-30129T
Reference: AKBR3012030
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-AMH

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723011
Basic UDI-DI: 692591270010GL
Reference: C86316
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details