- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- 06936020140638
- Basic UDI-DI
- 69360201208J
- Reference
- HCG-03-5t
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- -
- Authorised representative
- Obelis s.a.
- Last updated
- 19.07.2026 07:56
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
24.09.2026 21:30
Sync status
Successful
Device
3624323
Actor
47889
Certificate
3409
IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use
IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- 06936020141000
- Basic UDI-DI
- 6936020120BRB
- Reference
- HCG10-PP-01-2t
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- -
- Authorised representative
- Obelis s.a.
- Last updated
- 19.07.2026 07:56
IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- 06936020141017
- Basic UDI-DI
- 6936020120BRB
- Reference
- HCG10-PP-03-1t
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- -
- Authorised representative
- Obelis s.a.
- Last updated
- 19.07.2026 07:56
β-hCG Quantitative Test Kit (Time-Resolved FIA)
FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG
IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- 06950996003926
- Basic UDI-DI
- 69509960FAHCG-402a-DRAR
- Reference
- FAHCG-402a-DR10
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 18.07.2026 13:49
IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- 06950996003933
- Basic UDI-DI
- 69509960FAHCG-402a-DRAR
- Reference
- FAHCG-402a-DR
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- -
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 18.07.2026 13:47
hCG One Step Pregnancy Test
hCG-103a
IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- Manufacturer SRN
- CN-MF-000008447
- UDI-DI
- 06939663910712
- Basic UDI-DI
- B-06939663910712
- Reference
- hCG-103a
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- Spain
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 17.07.2026 23:07
FSH Rapid Test
FSH Rapid Test
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- 06936983101127
- Basic UDI-DI
- B-06936983101127
- Reference
- FFS-103H
- EMDN
- W0102160301
- EMDN description
- FSH - RT & POC
- First on market country
- Ireland
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 23:07
LH Ovulation Rapid Test
LH Ovulation Rapid Test
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- 06936983100526
- Basic UDI-DI
- B-06936983100526
- Reference
- FLH-103H
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Ireland
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 23:07
Pregnancy (hCG) Enhanced Sensitivity Rapid Test
Pregnancy (hCG) Enhanced Sensitivity Rapid Test
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- 06936983100519
- Basic UDI-DI
- B-06936983100519
- Reference
- FHC-U103H
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- Ireland
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 23:07
Pregnancy (hCG) Enhanced Sensitivity Rapid Test
Pregnancy (hCG) Enhanced Sensitivity Rapid Test
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- 05056668200974
- Basic UDI-DI
- B-05056668200974
- Reference
- FHC-U103H
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- Ireland
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 22:52
Accufast
Cassette
IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Acmex Bio-Technology (Chongqing) Co., Ltd.
- Manufacturer SRN
- CN-MF-000037745
- UDI-DI
- 06976232251395
- Basic UDI-DI
- B-06976232251395
- Reference
- CA01-09-422P1
- EMDN
- W0102160399
- EMDN description
- FERTILITY/PREGNANCY RT & POC - OTHER
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 17.07.2026 06:22
Validcheck®
Strip;Cassette;Midstream
IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- 08052742680424
- Basic UDI-DI
- 69360201208J
- Reference
- HCG-VC-03-1t
- EMDN
- W0102160302
- EMDN description
- HCG - RT & POC
- First on market country
- Italy
- Authorised representative
- Obelis s.a.
- Last updated
- 17.07.2026 05:30
LH Ovulation Rapid Test Dipstick
LH Ovulation Rapid Test Dipstick
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-U111CT
- Basic UDI-DI
- B-FLH-U111CT
- Reference
- FLH-U111
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Midstream
LH Ovulation Rapid Test Midstream
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-U103CU
- Basic UDI-DI
- B-FLH-U103CU
- Reference
- FLH-U103
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Cassette
LH Ovulation Rapid Test Cassette
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-U102CS
- Basic UDI-DI
- B-FLH-U102CS
- Reference
- FLH-U102
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Dipstick
LH Ovulation Rapid Test Dipstick
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-U101CQ
- Basic UDI-DI
- B-FLH-U101CQ
- Reference
- FLH-U101
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Cassette
LH Ovulation Rapid Test Cassette
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-S102H2L
- Basic UDI-DI
- B-FLH-S102H2L
- Reference
- FLH-S102H
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Midstream
LH Ovulation Rapid Test Midstream
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-M103HYJ
- Basic UDI-DI
- B-FLH-M103HYJ
- Reference
- FLH-M103H
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Midstream
LH Ovulation Rapid Test Midstream
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-M103B4
- Basic UDI-DI
- B-FLH-M103B4
- Reference
- FLH-M103
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01
LH Ovulation Rapid Test Cassette
LH Ovulation Rapid Test Cassette
IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
- Manufacturer SRN
- CN-MF-000010710
- UDI-DI
- D-FLH-M102HYF
- Basic UDI-DI
- B-FLH-M102HYF
- Reference
- FLH-M102H
- EMDN
- W0102160304
- EMDN description
- LH - RT & POC
- First on market country
- Austria
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 17.07.2026 05:01