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FPSA-RIACT

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321210
Basic UDI-DI: B-03770024321210
Reference: FPSA-RIACT
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ELSA-CYFRA-

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321159
Basic UDI-DI: B-03770024321159
Reference: ELSA-CYFRA-
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ELSA-CA125II

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321142
Basic UDI-DI: B-03770024321142
Reference: ELSA-CA125II
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ELSA-CA72-4

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321135
Basic UDI-DI: B-03770024321135
Reference: ELSA-CA72-4
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ELSA-CA19-9

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321111
Basic UDI-DI: B-03770024321111
Reference: ELSA-CA19-9
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ELSA-CA15-3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321104
Basic UDI-DI: B-03770024321104
Reference: ELSA-CA15-3
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

CEA-RIACT

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321043
Basic UDI-DI: B-03770024321043
Reference: CEA-RIACT
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

BIOSYNEX Bladder Tumor Antigen

Biosynex Bladder Tumor Antigen

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03700531700642
Basic UDI-DI: B-03700531700642
Reference: 1110004
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 19:26

Manufacturer products View details

BTM Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: möLab GmbH
Manufacturer SRN: DE-MF-000022941
UDI-DI: D-0230006TT
Basic UDI-DI: B-0230006TT
Reference: 0230006
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 16:16

Manufacturer products View details

CEA Test Kit (Fluorescence Immunoassay)

CEA Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807184067QX
Basic UDI-DI: B-000012807184067QX
Reference: HWTS-OT110
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064338
Basic UDI-DI: 69703416803205100HY
Reference: 0320510703
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ CEA Neo

ichroma™ CEA Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044056
Basic UDI-DI: 880613300124BN
Reference: CFPC-158
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Cyfra21-1

ichroma™ Cyfra21-1

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043929
Basic UDI-DI: 880613300131BK
Reference: CFPC-140
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ CA19-9

ichroma™ CA19-9

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043837
Basic UDI-DI: 880613300130BH
Reference: CFPC-139
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Free PSA

ichroma™ Free PSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043745
Basic UDI-DI: 880613303018CB
Reference: CFPC-178
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PSA Neo

ichroma™ PSA Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043585
Basic UDI-DI: 880613300133BP
Reference: CFPC-157
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PROGRP

HOKAPI™ PROGRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404694
Basic UDI-DI: 69713904301227H
Reference: 010122001
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HE4

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404632
Basic UDI-DI: 69713904301147J
Reference: 010114001
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SCC

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404618
Basic UDI-DI: 69713904301137G
Reference: 010113001
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CA 72-4

HOKAPI™ CA72-4

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404571
Basic UDI-DI: 69713904301117C
Reference: 010111001
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details