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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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FSH Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349YS003Q2
Basic UDI-DI: B-CNMF000054349YS003Q2
Reference: YS003
EMDN: W0102160301
EMDN description: FSH - RT & POC
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

LH Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349YS001PW
Basic UDI-DI: B-CNMF000054349YS001PW
Reference: YS001
EMDN: W0102160304
EMDN description: LH - RT & POC
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

D-CNM0000180726003N4

Strip, Cassette, Midstream and Urine Cup

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180726003N4
Basic UDI-DI: B-CNM0000180726003N4
Reference: 6003C 6003S 6003D 6003B
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Romania
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNM0000180726002N2

Strip, Cassette , Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180726002N2
Basic UDI-DI: B-CNM0000180726002N2
Reference: 6002S 6002C 6002D
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Romania
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNM0000180726001MY

Cassette, Strip, Midstream, Urine Cup

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180726001MY
Basic UDI-DI: B-CNM0000180726001MY
Reference: 6001C 6001S 6001D 6001B
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Romania
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

AMH 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-AMH-D06a9L
Basic UDI-DI: B-AMH-D06a9L
Reference: AMH-D06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Ovulation Test

Strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21003-S07-016DT
Basic UDI-DI: B-ACK21003-S07-016DT
Reference: ACK21003-S07-016
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Pregnancy Test 2in1

Strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21001-S02-018AS
Basic UDI-DI: B-ACK21001-S02-018AS
Reference: ACK21001-S02-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Pregnancy Test Comfort

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21001-M01-01879
Basic UDI-DI: B-ACK21001-M01-01879
Reference: ACK21001-M01-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Pregnancy Test

Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21001-C01-018ZU
Basic UDI-DI: B-ACK21001-C01-018ZU
Reference: ACK21001-C01-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Pregnancy Test

Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-C123
Basic UDI-DI: B-ABT-FT-C123
Reference: ABT-FT-C1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HCG Multi-Line Midstream (Urine)

Midstream

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-C387PM
Basic UDI-DI: B-ABT-FT-C387PM
Reference: ABT-FT-C387
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step LH Ovulation Test

Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-C327
Basic UDI-DI: B-ABT-FT-C327
Reference: ABT-FT-C3
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step LH Ovulation Test

Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-B324
Basic UDI-DI: B-ABT-FT-B324
Reference: ABT-FT-B3
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Pregnancy Test

Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-B1ZV
Basic UDI-DI: B-ABT-FT-B1ZV
Reference: ABT-FT-B1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step LH Ovulation Test

Strip

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-A3ZW
Basic UDI-DI: B-ABT-FT-A3ZW
Reference: ABT-FT-A3
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HCG Multi-Line Strip (Urine)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-A387P7
Basic UDI-DI: B-ABT-FT-A387P7
Reference: ABT-FT-A387
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Pregnancy Test

Strip

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-A1ZS
Basic UDI-DI: B-ABT-FT-A1ZS
Reference: ABT-FT-A1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Test Kit(Urine)

HCG0034

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610139
Basic UDI-DI: B-86979834610139
Reference: HCG0034
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Digital Pregnancy Rapid Test

DC811

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: D-8595566428563GB
Basic UDI-DI: B-8595566428563GB
Reference: 0811S7X001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details