- Manufacturer
- Monobind Inc.
- Manufacturer SRN
- US-MF-000021611
- UDI-DI
- 00816870020426
- Basic UDI-DI
- 081687002PSAVAST842522
- Reference
- 8425-300B
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- -
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 04:22
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
04.08.2026 18:01
Sync status
Successful
Device
3011958
Actor
47535
Certificate
3185
IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing
IVD Class CIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- 06950996003773
- Basic UDI-DI
- 69509960FEPSA-402a-DRZB
- Reference
- FEPSA-402a-DR
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- -
- Safety summary (SSCP/SSP)
- CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 16.07.2026 03:57
IVD Class CIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- 06950996061162
- Basic UDI-DI
- 69509960FEPSA-402a-DRZB
- Reference
- FEPSA-402a-DR10LH
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- -
- Safety summary (SSCP/SSP)
- CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 16.07.2026 03:57
IVD Class CIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- 06950996064521
- Basic UDI-DI
- 69509960FEPSA-402a-DRZB
- Reference
- FEPSA-402a-DRLH
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- -
- Safety summary (SSCP/SSP)
- CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 16.07.2026 03:57
ADVIA Centaur fPSA
IVDR_67_TTN_DUB-C_C_KIT_Free Prostate-Specific Antigen
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414553344
- Basic UDI-DI
- 0405686901812VR
- Reference
- 10283414
- EMDN
- W0102030114
- EMDN description
- FREE PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:34
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
- 00630414461298
- Basic UDI-DI
- 0405686901800VJ
- Reference
- 10310443
- EMDN
- W0102030106
- EMDN description
- CANCER ANTIGEN 125
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:34
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
ADVIA Centaur® cPSA
IVDR_67_TTN_DUB-C_C_KIT_cPSA
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414450896
- Basic UDI-DI
- 0405686901806VW
- Reference
- 10310381
- EMDN
- W0102030115
- EMDN description
- COMPLEXED PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:33
Atellica IM fPSAII
IVDR_67_TTN_DUB-C_C_REAG_KIT_fPSAII
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414285580
- Basic UDI-DI
- 0405686902253VG
- Reference
- 11202221
- EMDN
- W0102030114
- EMDN description
- FREE PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:33
Atellica IM total PSA II
IVDR_67_TTN_DUB-C_C_REAG_KIT_hsPSA
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414240138
- Basic UDI-DI
- 0405686902251VC
- Reference
- 11202246
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:33
ADVIA Centaur® PSA
IVDR_67_TTN_DUB-C_C_KIT_Prostate-Specific Antigen
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414202990
- Basic UDI-DI
- 0405686901820VQ
- Reference
- 10310293
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:32
ADVIA Centaur® 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
- 00630414177304
- Basic UDI-DI
- 0405686901803VQ
- Reference
- 10309977
- EMDN
- W0102030112
- EMDN description
- CARCINOEMBRYONIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:32
Dimension Total Prostate Specific Antigen Flex reagent cartridge
IVDR_67_GLA_DUB-C_C_REAG_TPSA
IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016336
- UDI-DI
- 00842768013874
- Basic UDI-DI
- 0405686901314V4
- Reference
- 10444889
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:29
IMMULITE 2000 PSA
IVDR_67_LLB_DUB-C_C_REAG_KIT_PSA
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Manufacturer SRN
- GB-MF-000016339
- UDI-DI
- 00630414961958
- Basic UDI-DI
- 0405686901460VG
- Reference
- 10380986
- EMDN
- W0102030113
- EMDN description
- TOTAL PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:26
IMMULITE 2000 Free PSA
IVDR_67_LLB_DUB-C_C_KIT_Free PSA
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Manufacturer SRN
- GB-MF-000016339
- UDI-DI
- 00630414961897
- Basic UDI-DI
- 0405686901451VF
- Reference
- 10380984
- EMDN
- W0102030114
- EMDN description
- FREE PROSTATIC SPECIFIC ANTIGEN
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:26
IMMULITE 2000 PAP
IVDR_67_LLB_DUB-C_C_REAG_KIT_PAP
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Manufacturer SRN
- GB-MF-000016339
- UDI-DI
- 00630414961804
- Basic UDI-DI
- 0405686901457VT
- Reference
- 10380975
- EMDN
- W0102030120
- EMDN description
- PROSTATIC ACID PHOSPHATASE (IC)
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:25
IMMULITE 2000 GI-MA
IVDR_67_LLB_DUB-C_C_KIT_GI-MA
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Manufacturer SRN
- GB-MF-000016339
- UDI-DI
- 00630414961545
- Basic UDI-DI
- 0405686901452VH
- Reference
- 10380988
- EMDN
- W0102030103
- EMDN description
- CANCER ANTIGEN 19-9
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:25
IMMULITE 2000 OM-MA
IVDR_67_LLB_DUB-C_C_KIT_OM-MA
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Manufacturer SRN
- GB-MF-000016339
- UDI-DI
- 00630414961798
- Basic UDI-DI
- 0405686900729VW
- Reference
- 10380972
- EMDN
- W0102030106
- EMDN description
- CANCER ANTIGEN 125
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:16
ADVIA Centaur® CA 19-9™
IVDR_67_TTN_DUB-C_C_KIT_CA 19-9
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414574028
- Basic UDI-DI
- 0405686900806VP
- Reference
- 10491244
- EMDN
- W0102030103
- EMDN description
- CANCER ANTIGEN 19-9
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:13
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414598086
- Basic UDI-DI
- 0405686901800VJ
- Reference
- 10995481
- EMDN
- W0102030106
- EMDN description
- CANCER ANTIGEN 125
- First on market country
- -
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 15.07.2026 22:50