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45 device results listed.

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++B261CANE630DQ

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANE630DQ
Basic UDI-DI: B-++B261CANE630DQ
Reference: CAN-E-630
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Laboquick

LBHG.01

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

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610037
Basic UDI-DI: 869919561003LBHG.014V
Reference: LBHG.01
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

Manufacturer products View details

AFP screening IRMA KIT

Immunoassay A37404

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590203139
Basic UDI-DI: 150995905A37404SN
Reference: A37404
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

iGFBP-1 Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308440
Basic UDI-DI: B-69743840308440
Reference: 3010201
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

fFN Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304794
Basic UDI-DI: B-69743840304794
Reference: 3010301
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-3548

PLGF & sFLT-1 Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-3548
Basic UDI-DI: B-TD-HNKX-CED-3548
Reference: /
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

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-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

Sharay Anti-Trophoblast Cell Membrane (CLIA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460055
Basic UDI-DI: B-06980070460055
Reference: 14000777
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-hCG IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460048
Basic UDI-DI: B-06980070460048
Reference: 14000778
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

06975260987221

β-HCG Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260987221
Basic UDI-DI: B-06975260987221
Reference: 0043-03
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Fibronectin Rapid Test Kit (Colloidal gold method)

YS010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308700
Basic UDI-DI: B-06974473308700
Reference: YS010
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720138084
Basic UDI-DI: B-06973720138084
Reference: W-IF-β-HCG-20
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method)

40 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720131764
Basic UDI-DI: B-06973720131764
Reference: W-IF-AMH-40
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720131757
Basic UDI-DI: B-06973720131757
Reference: W-IF-AMH-20
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method)

40 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06973720131634
Basic UDI-DI: B-06973720131634
Reference: W-IF-β-HCG-40
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Toda Preterm Diag

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511153
Basic UDI-DI: B-03760309511153
Reference: 21GO1-1
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

Toda Preterm Diag 10

Toda Preterm Diag

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511146
Basic UDI-DI: B-03760309511146
Reference: 21GO1-10
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

Toda Preterm Diag 20

Toda Preterm Diag

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511139
Basic UDI-DI: B-03760309511139
Reference: 21GO1-20
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details