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174 device results listed.

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D-W35-CUR

One Step Chlamydia Swab / Urine Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W35-CUR
Basic UDI-DI: B-W35-CUR
Reference: W35-C
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W31-SV5

One Step Prostate Specific Antigen (PSA) Serum/Plasma Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W31-SV5
Basic UDI-DI: B-W31-SV5
Reference: W31-S
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W31-S4PNE

One Step Prostate Specific Antigen (PSA) Whole Blood/Serum/Plasma Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W31-S4PNE
Basic UDI-DI: B-W31-S4PNE
Reference: W31-S4P
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W31-CU5

One Step Prostate Specific Antigen (PSA) Serum/Plasma Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W31-CU5
Basic UDI-DI: B-W31-CU5
Reference: W31-C
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W31-C4PKW

One Step Prostate Specific Antigen (PSA) Whole Blood/Serum/Plasma Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W31-C4PKW
Basic UDI-DI: B-W31-C4PKW
Reference: W31-C4P
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W230HU

Finecare™ FPSA (Free Prostate Specific Antigen) Rapid Quantitative Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W230HU
Basic UDI-DI: B-W230HU
Reference: W230
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W209J5

Finecare™ PSA Rapid Quantitative Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W209J5
Basic UDI-DI: B-W209J5
Reference: W209
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
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

D-W2-SKE

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

D-W2-MK2

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

D-W2-CJE

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

D-W135-C4U

Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatographic Assay)

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W135-C4U
Basic UDI-DI: B-W135-C4U
Reference: W135-C
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
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

D-W121-S4Z

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

D-W121-C3Z

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

D-W1-SK9

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

D-W1-S-20mIUNQ

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

D-W1-S-10mIUND

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

D-W1-MJV

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

D-W1-M-10mIUK7

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

D-W1-M-20mIUKJ

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

D-W1-C-20mIUE8

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