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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

Simple hCG s&o / Stick hCG s&o

9.005.XXX.YY.ZZZ

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779005XKH9
Basic UDI-DI: B-84295779005XKH9
Reference: 9.005.XXX.YY.ZZZ
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

safe & easy

Ovulationstest

IVD self-testing devicesIVDDNo longer on the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-823150PW
Basic UDI-DI: B-823150PW
Reference: 823150-5
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Luxembourg
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 10:07

Manufacturer products Authorised representative products Authorised representative actors View details

Securtest Test di Ovulazione

Test di Ovulazione

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-821050PB
Basic UDI-DI: B-821050PB
Reference: 821050
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
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

FertiQUICK

FertiQUICK [BG/EN]

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: NanoRepro AG
Manufacturer SRN: DE-MF-000023735
UDI-DI: D-820008P5
Basic UDI-DI: B-820008P5
Reference: 820008
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: -
Last updated: 12.07.2026 10:06

Manufacturer products View details

FertiQUICK

FertiQUICK [HU/EN/RO/PL]

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: NanoRepro AG
Manufacturer SRN: DE-MF-000023735
UDI-DI: D-820007P3
Basic UDI-DI: B-820007P3
Reference: 820007
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 12.07.2026 10:06

Manufacturer products View details