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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

PRL (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: D-CNMF000042193PRLPT
Basic UDI-DI: B-CNMF000042193PRLPT
Reference: 48 tests/kit: (Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:06

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ASD Androstenedione (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ASD706-AET3
Basic UDI-DI: B-ASD706-AET3
Reference: ASD706-AE10Y, ASD706-AE10N, ASD706-AE20Y, ASD706-AE20N
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:44

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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D-AKBR3041030DR

Estradiol in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-AKBR3041030DR
Basic UDI-DI: B-AKBR3041030DR
Reference: AKBR3041030
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 21:34

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D-AKBR3039030F6

Follicle Stimulating Hormone in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-AKBR3039030F6
Basic UDI-DI: B-AKBR3039030F6
Reference: AKBR3039030
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

D-AKBR3016030DT

Progesterone in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-AKBR3016030DT
Basic UDI-DI: B-AKBR3016030DT
Reference: AKBR3016030
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Sperm Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A032CU
Basic UDI-DI: B-A032CU
Reference: INDICAID™ Sperm Rapid Test
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Estromineral

820011-x

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-822011P8
Basic UDI-DI: B-822011P8
Reference: 822011-2H
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 10:07

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7M34FD
Basic UDI-DI: B-7M34FD
Reference: 7M34V1-B-EU, 7M34U1-B-EU, 7M34P1-B-EU
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
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