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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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FHC-102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-102KZ
Basic UDI-DI: B-FHC-102KZ
Reference: FHC-102
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

FHC-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-101KX
Basic UDI-DI: B-FHC-101KX
Reference: FHC-101
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

LH Quantitative Test Kit (Time-Resolved FIA)

FALH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FALH-402aVU
Basic UDI-DI: B-FALH-402aVU
Reference: FALH-402a
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

LH Quantitative Test Kit (Time-Resolved FIA)

FALH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FALH-402aHGJ2
Basic UDI-DI: B-FALH-402aHGJ2
Reference: FALH-402a
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAHCG-402aQ5
Basic UDI-DI: B-FAHCG-402aQ5
Reference: FAHCG-402a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAHCG-402aHGKV
Basic UDI-DI: B-FAHCG-402aHGKV
Reference: FAHCG-402a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Quantitative Test Kit (Time-Resolved FIA)

FAFSH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAFSH-402aXU
Basic UDI-DI: B-FAFSH-402aXU
Reference: FAFSH-402a
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Quantitative Test Kit (Time-Resolved FIA)

FAFSH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAFSH-402aHGW6
Basic UDI-DI: B-FAFSH-402aHGW6
Reference: FAFSH-402a
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH)Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0021YY
Basic UDI-DI: B-FA0021YY
Reference: 52027076
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0020YW
Basic UDI-DI: B-FA0020YW
Reference: 52027075
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy (hCG) Rapid Test

Pregnancy (hCG) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: D-F001-1001RH
Basic UDI-DI: B-F001-1001RH
Reference: F001-1001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 21:10

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Ovulation Test

Easy@Home Ovulation Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-EZW2-SKG
Basic UDI-DI: B-EZW2-SKG
Reference: EZW2-S
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Pregnancy Test

Easy@Home Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-EZW1-SKB
Basic UDI-DI: B-EZW1-SKB
Reference: EZW1-S
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-S-5

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-S-5PM
Basic UDI-DI: B-EZW1-S-5PM
Reference: EZW1-S-5
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Pregnancy Test

EZW1-S-20

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-S-20CD
Basic UDI-DI: B-EZW1-S-20CD
Reference: EZW1-S-20
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-MN-5

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-MN-5FW
Basic UDI-DI: B-EZW1-MN-5FW
Reference: EZW1-MN-5
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-MN-2

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-MN-2FQ
Basic UDI-DI: B-EZW1-MN-2FQ
Reference: EZW1-MN-2
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZM1-H3

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZM1-H3YP
Basic UDI-DI: B-EZM1-H3YP
Reference: EZM1-H3
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

E2 Test Kit FIA

E2 Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-E2-D06aBH
Basic UDI-DI: B-E2-D06aBH
Reference: E2-D06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation and Pregnancy Test Combi Pack

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: Sanavita Pharmaceuticals GmbH
Manufacturer SRN: DE-MF-000005463
UDI-DI: D-COMBIPACKLB
Basic UDI-DI: B-COMBIPACKLB
Reference: COMBIPACK
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 13.07.2026 07:09

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