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Access Hybritech PSA (Reagent Pack)

37200

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224592
Basic UDI-DI: 150995901AccHPSA2E
Reference: 37200
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-Z003384P

N/A

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z003384P
Basic UDI-DI: B-Z003384P
Reference: Z00338
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

LIAISON® PSA II Gen

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103619
Basic UDI-DI: 80567713113203S
Reference: 311320
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products 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

AFIAS PSA Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043653
Basic UDI-DI: 880613300621C9
Reference: SMFP-130
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

06973224897319

30 Tests/kit

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

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224897319
Basic UDI-DI: 6973224890064AL
Reference: DC76092
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

06950996003766

10 tests/kit

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: 06950996003766
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DR10
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
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 10:48

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

06950996003773

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

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

06950996061162

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

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

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

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

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4407106GJ
Basic UDI-DI: B-EIM4407106GJ
Reference: EIM4407106
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4406106GB

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4406106GB
Basic UDI-DI: B-EIM4406106GB
Reference: EIM4406106
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4405106G4

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4405106G4
Basic UDI-DI: B-EIM4405106G4
Reference: EIM4405106
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4403106FN

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4403106FN
Basic UDI-DI: B-EIM4403106FN
Reference: EIM4403106
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details