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EUDAMED Device Search

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Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251807
Basic UDI-DI: B-06976232251807
Reference: CA01-12-422P25
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Accufast

Strip

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251760
Basic UDI-DI: B-06976232251760
Reference: CA01-11-113P10
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

Veroval Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598216019
Basic UDI-DI: B-06942598216019
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Early Pregnancy test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468139202
Basic UDI-DI: B-06942468139202
Reference: ACK21001- M02-001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Pregnancy test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468139196
Basic UDI-DI: B-06942468139196
Reference: ACK21002- M02-001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Ovulation test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468139189
Basic UDI-DI: B-06942468139189
Reference: ACK21003-M05-001
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Ovulation test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468138403
Basic UDI-DI: B-06942468138403
Reference: ACK21003-M05-001
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Pregnancy test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468138397
Basic UDI-DI: B-06942468138397
Reference: ACK21002- M02-001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

vitalio Early Pregnancy test

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468138380
Basic UDI-DI: B-06942468138380
Reference: ACK21001- M02-001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

Toto Pharma

WHCG-ES11H

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: 06934078096501
Basic UDI-DI: B-06934078096501
Reference: WHCG-ES11H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Slovakia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST FSH Rapid Test Midstream

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173434118
Basic UDI-DI: B-04260173434118
Reference: FFS-103H
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST Ovulation (LH) Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173434071
Basic UDI-DI: B-04260173434071
Reference: FLH-S103H
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

NanoRepro Pregnancy (hCG)10miu Enhanced Sensitivity Rapid Test Dipstick

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173434064
Basic UDI-DI: B-04260173434064
Reference: FHC-U101H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173434033
Basic UDI-DI: B-04260173434033
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST FSH Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433951
Basic UDI-DI: B-04260173433951
Reference: FFS-103H
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

Mivolis Ovulation (LH) Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04066447834185
Basic UDI-DI: B-04066447834185
Reference: FLH-U103H
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

Mivolis Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04066447834161
Basic UDI-DI: B-04066447834161
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

Mivolis Pregnancy (hCG)10miu Enhanced Sensitivity Rapid Test Dipstick

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04066447834147
Basic UDI-DI: B-04066447834147
Reference: FHC-U101H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

MIRATECH Luteinizing Hormone Tests for self-testing

A01-03-130MT5

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347568290
Basic UDI-DI: B-00628347568290
Reference: A01-03-130MT5
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details

LifeClues Ovulation Test

L01-03-113S100

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347566227
Basic UDI-DI: B-00628347566227
Reference: L01-03-113S100
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 13:25

Manufacturer products Authorised representative products Authorised representative actors View details