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112 device results listed.

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IMMULITE 2000 BR-MA

IVDR_67_LLB_DUB-C_C_KIT_BR-MA

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961088
Basic UDI-DI: 0405686901441VC
Reference: 10380983
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-73AM

Cancer Antigen 15-3(CA15-3)Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-73AM
Basic UDI-DI: B-6-73AM
Reference: "REF: USIA00000131M, USIA00000132M"
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

CA 15-3 AccuLite CLIA Kit - 96 wells

5675-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022178
Basic UDI-DI: 081687002CA1535675S4
Reference: 5675-300A
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® CA 15-3®

IVDR_67_TTN_DUB-C_C_KIT_CA 15-3

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461311
Basic UDI-DI: 0405686901801VL
Reference: 10327620
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 15-3 (CA15-3)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598130
Basic UDI-DI: 0405686901801VL
Reference: 10995486
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 15-3 (CA15-3)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598123
Basic UDI-DI: 0405686901801VL
Reference: 10995485
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK002DA
Basic UDI-DI: B-SEK002DA
Reference: SE-K002
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA15-3 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA15-3-01100C3X
Basic UDI-DI: B-KR-CA15-3-01100C3X
Reference: KR-CA15-3-01100C
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD186Y2
Basic UDI-DI: B-GKPD186Y2
Reference: GKPD186
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA15-3

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76423FT
Basic UDI-DI: B-DC76423FT
Reference: DC76423
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA15-3

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76422FR
Basic UDI-DI: B-DC76422FR
Reference: DC76422
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA15-3

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76421FP
Basic UDI-DI: B-DC76421FP
Reference: DC76421
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA15-3

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76420FM
Basic UDI-DI: B-DC76420FM
Reference: DC76420
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-CA15-3

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76040F7
Basic UDI-DI: B-DC76040F7
Reference: DC76040
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Cancer Antigen 15-3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA15-3706-AEZE
Basic UDI-DI: B-CA15-3706-AEZE
Reference: CA15-3706-AE10Y, CA15-3706-AE10N, CA15-3706-AE20Y, CA15-3706-AE20N
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C10DD
Basic UDI-DI: B-7C10DD
Reference: 7C10V1-B-EU, 7C10U1-B-EU, 7C10P1-B-EU
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-32879

Cancer Antigen 15-3 Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-32879
Basic UDI-DI: B-32879
Reference: /
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

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: 06925912723035
Basic UDI-DI: 692591270025GZ
Reference: C86006-S
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

CanAg CA15-3 EIA

200-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140081
Basic UDI-DI: B-17350066140081
Reference: 200-10
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

14562185399438

CL AIA-PACK 27.29 ADJUSTER SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185399438
Basic UDI-DI: B-14562185399438
Reference: 0029211
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details