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IMMULITE 2000 CEA

IVDR_67_LLB_DUB-C_C_KIT_Carcinoembryonic Antigen

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961118
Basic UDI-DI: 0405686901443VG
Reference: 10380994
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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

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

Atellica IM Complexed Prostate-Specific Antigen (cPSA)

IVDR_67_TTN_DUB-C_C_KIT_cPSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598680
Basic UDI-DI: 0405686901806VW
Reference: 10995544
EMDN: W0102030115
EMDN description: COMPLEXED PROSTATIC SPECIFIC ANTIGEN
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

Atellica IM BR 27.29 Pretreatment Reagent (BR PRE)

IVDR_67_TTN_DUB-C_C_REAG_BR Pretreatment

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598079
Basic UDI-DI: 0405686901827W6
Reference: 10995480
EMDN: W0102030110
EMDN description: CANCER ANTIGEN 27.29
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

Atellica IM Carcinoembryonic Antigen (CEA)

IVDR_67_TTN_DUB-C_C_KIT_CEA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598505
Basic UDI-DI: 0405686901803VQ
Reference: 10995523
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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

ADVIA Centaur CA 125II

IVDR_67_TTN_DUB-C_C_KIT_CA 125II

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461304
Basic UDI-DI: 0405686901800VJ
Reference: 10315696
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BR

IVDR_67_TTN_DUB-C_C_KIT_BR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414196657
Basic UDI-DI: 0405686901799WS
Reference: 10333349
EMDN: W0102030110
EMDN description: CANCER ANTIGEN 27.29
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GECEA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GECEA-402aOGJW
Basic UDI-DI: B-GECEA-402aOGJW
Reference: GECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Bladder Cancer Marker NMP22 Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A038D8
Basic UDI-DI: B-A038D8
Reference: INDICAID™ Bladder Cancer Marker NMP22 Test
EMDN: W0102030123
EMDN description: NUCLEAR MATRIX PROTEIN 22
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0553ME7

Human Bladder Tumor Antigen (BTA) Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0553ME7
Basic UDI-DI: B-697994388Ir0553ME7
Reference: Ir055
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0523FDA

CEA Carcinoma Embryonic Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0523FDA
Basic UDI-DI: B-697994388Ir0523FDA
Reference: Ir052
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0513DCZ

AFP Alpha Fetoprotein Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0513DCZ
Basic UDI-DI: B-697994388Ir0513DCZ
Reference: Ir051
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

CEA (Carcinoembryonic Antigen) Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309676
Basic UDI-DI: B-69743840309676
Reference: 3040601
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308136
Basic UDI-DI: B-69743840308136
Reference: 3040301
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Test

strip cassette

IVD Annex II List BIVDDOn the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990607QK
Basic UDI-DI: B-693757990607QK
Reference: strip cassette
EMDN: W0102030122
EMDN description: EARLY PROSTATE CANCER ANTIGEN - 2
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-81AL

Cancer Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Microparticle Immunoassay)