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754 device results listed.

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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

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: 20850076346205
Basic UDI-DI: B-20850076346205
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 15:02

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: 20850076346199
Basic UDI-DI: B-20850076346199
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 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

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