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138 device results listed.

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IRMA MUC-1 gene associated antigen (CA 15-3)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590666323
Basic UDI-DI: 150995905CA15-3IRMAMG
Reference: B64314
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:49

Manufacturer products View details

Carbohydrate antigen 15-3 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701397
Basic UDI-DI: B-06955792701397
Reference: S2105E-24
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate antigen 15-3 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701250
Basic UDI-DI: B-06955792701250
Reference: S2105E-48
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Getein

MAGICL CA15-3 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798272
Basic UDI-DI: B-06954414798272
Reference: /
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702699
Basic UDI-DI: B-06954414702699
Reference: /
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334817918
Basic UDI-DI: B-06950334817918
Reference: 52026235
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

DiaRapid CA15-3 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598212462
Basic UDI-DI: B-06942598212462
Reference: S153-402
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590230
Basic UDI-DI: 697518250F1220625
Reference: F12206
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 153 Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580163
Basic UDI-DI: 697518250P1220667
Reference: P12206
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

06941967231103

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231103
Basic UDI-DI: B-06941967231103
Reference: 0601901
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CA 15-3

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404502
Basic UDI-DI: 69713904301077M
Reference: 010107601
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300407

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300407
Basic UDI-DI: B-06937287300407
Reference: 100 tests/kit
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

06936595751253

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751253
Basic UDI-DI: B-06936595751253
Reference: FG1201Y
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CA 15-3

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718468
Basic UDI-DI: 692591270025GZ
Reference: C86006
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207367
Basic UDI-DI: B-06933260207367
Reference: BT0506005
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207343
Basic UDI-DI: B-06933260207343
Reference: BT0506003
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207336
Basic UDI-DI: B-06933260207336
Reference: BT0506002
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® CA 15-3®

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461328
Basic UDI-DI: 0405686901801VL
Reference: 10312831
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details