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Active filter:EMDN:W01060215

18 device results listed.

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D-697180825KFP009HCWE

Bladder Cancer Cells chromosome and gene anomaly probe detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KFP009HCWE
Basic UDI-DI: B-697180825KFP009HCWE
Reference: FP-009
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time PCR)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931305196
Basic UDI-DI: B-06955931305196
Reference: 213101
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time PCR)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931305189
Basic UDI-DI: B-06955931305189
Reference: 213101
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Bladder Cancer Monitor

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002282
Basic UDI-DI: B-07332940002282
Reference: GXBLAD-CM-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Bladder Cancer Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002268
Basic UDI-DI: B-07332940002268
Reference: GXBLAD-CD-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

UROMONITOR

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Infogene, Lda.
Manufacturer SRN: PT-MF-000047847
UDI-DI: D-infogene_CP
Basic UDI-DI: B-infogene_CP
Reference: UROM01
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Portugal
Authorised representative: -
Last updated: 15.07.2026 14:19

Manufacturer products View details

INDICAID™ Bladder Cancer Mutation Gene Test (Urine, Gene sequencing technology)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A028D5
Basic UDI-DI: B-A028D5
Reference: INDICAID™ Bladder Cancer Mutation Gene Test (Urine, Gene sequencing technology)
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Bladder Cancer Methylation Test (Urine, Gene sequencing technology)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A027D3
Basic UDI-DI: B-A027D3
Reference: INDICAID™ Bladder Cancer Methylation Test (Urine, Gene sequencing technology)
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Bladder Cancer Methylation Test (Urine, PCR-fluorescence probe method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A026CZ
Basic UDI-DI: B-A026CZ
Reference: INDICAID™ Bladder Cancer Methylation Test (Urine, PCR-fluorescence probe method)
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

06975585300026

96 tests/kit

IVD generalIVDDOn the marketHuman tissuesKitReagentSingle use

Manufacturer: Ankang Euler Technology Co., LTD
Manufacturer SRN: CN-MF-000027199
UDI-DI: 06975585300026
Basic UDI-DI: B-06975585300026
Reference: S303
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975240820159

40 Tests

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: AnchorDx Medical Co.Ltd.
Manufacturer SRN: CN-MF-000054821
UDI-DI: 06975240820159
Basic UDI-DI: B-06975240820159
Reference: 40 Tests
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Urothelial carcinoma-associated gene methylation digital PCR detection kit

UC01-Y24