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746 device results listed.

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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

D-W1-CJ9

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

D-W1-C-10mIUDV

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

D-W039P0001N5

One Step Strep A Swab Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W039P0001N5
Basic UDI-DI: B-W039P0001N5
Reference: W039P0001
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-W030-S(50ng/ml)HE

One Step Fecal Occult Blood (FOB)Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W030-S(50ng/ml)HE
Basic UDI-DI: B-W030-S(50ng/ml)HE
Reference: W030-S(50ng/ml)
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-W030-C(50ng/ml)2W

One Step Fecal Occult Blood (FOB)Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W030-C(50ng/ml)2W
Basic UDI-DI: B-W030-C(50ng/ml)2W
Reference: W030-C(50ng/ml)
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Ovulation Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-EZW2-SKG
Basic UDI-DI: B-EZW2-SKG
Reference: EZW2-S
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-EZW1-SKB
Basic UDI-DI: B-EZW1-SKB
Reference: EZW1-S
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

06933289846059

PA-Immunochromogenic Reagent (Dual staining)

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289846059
Basic UDI-DI: 69332898CE4485GJ
Reference: WDB1P0001
EMDN: W01030710
EMDN description: SECONDARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details