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06950996064521

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

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

D-W209J5

Finecare™ PSA Rapid Quantitative Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W209J5
Basic UDI-DI: B-W209J5
Reference: W209
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Prostate-Specific Antigen (PSA)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599816
Basic UDI-DI: 0405686901820VQ
Reference: 10995663
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Prostate-Specific Antigen (PSA)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599809
Basic UDI-DI: 0405686901820VQ
Reference: 10995662
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4407106GJ