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EUDAMED Device Search

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One Step Ovulation Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W2-SKE
Basic UDI-DI: B-W2-SKE
Reference: W2 –S
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W2-MK2
Basic UDI-DI: B-W2-MK2
Reference: W2-M
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W2-CJE
Basic UDI-DI: B-W2-CJE
Reference: W2-C
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

Sperm Concentration Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W121-S4Z
Basic UDI-DI: B-W121-S4Z
Reference: W121-S
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

Sperm Concentration Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W121-C3Z
Basic UDI-DI: B-W121-C3Z
Reference: W121-C
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-SK9
Basic UDI-DI: B-W1-SK9
Reference: W1-S
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-S-20mIUNQ
Basic UDI-DI: B-W1-S-20mIUNQ
Reference: W1-S (20mIU)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-S-10mIUND
Basic UDI-DI: B-W1-S-10mIUND
Reference: W1-S (10mIU)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-MJV
Basic UDI-DI: B-W1-MJV
Reference: W1-M
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-M-10mIUK7
Basic UDI-DI: B-W1-M-10mIUK7
Reference: W1-M (10mIU)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-M-20mIUKJ
Basic UDI-DI: B-W1-M-20mIUKJ
Reference: W1-M (20mIU)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-C-20mIUE8
Basic UDI-DI: B-W1-C-20mIUE8
Reference: W1-C (20mIU)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-CJ9
Basic UDI-DI: B-W1-CJ9
Reference: W1-C
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W1-C-10mIUDV
Basic UDI-DI: B-W1-C-10mIUDV
Reference: W1-C (10mIU)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test

VHIG-702

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VHIG-702MK
Basic UDI-DI: B-VHIG-702MK
Reference: VHIG-702
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:17

Manufacturer products Authorised representative products Authorised representative actors View details

Testo Test Kit FIA

Testo 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-TESTO-C06aW2
Basic UDI-DI: B-TESTO-C06aW2
Reference: TESTO-C06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

SP-10 Rapid Test

SP-10 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SP10-K02aVR
Basic UDI-DI: B-SP10-K02aVR
Reference: SP10-K02a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i LH

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724145
Basic UDI-DI: 88001117IPBA01IA33W6
Reference: 16LH10F
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i LH

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724152
Basic UDI-DI: 88001117IPBA01IA33W6
Reference: 16LH10Q
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

RPOG Test Kit FIA

RPOG 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-RPOG-C06aL4
Basic UDI-DI: B-RPOG-C06aL4
Reference: RPOG-C06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details