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117 device results listed.

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HOKAPI™ PSA

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390434987
Basic UDI-DI: 69713904301037D
Reference: 010103101
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:01

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685508
Basic UDI-DI: 69703416803205053JG
Reference: 0320501104
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685492
Basic UDI-DI: 69703416803205053JG
Reference: 0320501103
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685485
Basic UDI-DI: 69703416803205053JG
Reference: 0320501102
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685478
Basic UDI-DI: 69703416803205053JG
Reference: 0320501101
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

tPSA CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908294
Basic UDI-DI: 697015090000111GS
Reference: CMB0302
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech PSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590701673
Basic UDI-DI: 150995901AccHPSA2E
Reference: C22845
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

DiaRapid PSA Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598212509
Basic UDI-DI: B-06942598212509
Reference: SPS-402
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors View details

Total prostate specific antigen CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590278
Basic UDI-DI: 697518250F1221424
Reference: F12214
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580415
Basic UDI-DI: 697518250P122015V
Reference: P12201
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PSA

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404427
Basic UDI-DI: 69713904301037D
Reference: 010103601
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289810241
Basic UDI-DI: B-06933289810241
Reference: W209
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® PSA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414203003
Basic UDI-DI: 0405686901820VQ
Reference: 10310292
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 PSA

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961965
Basic UDI-DI: 0405686901460VG
Reference: 10380996
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM total PSA II

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414240145
Basic UDI-DI: 0405686902251VC
Reference: 11202247
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 18.06.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606469

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606469
Basic UDI-DI: 69268026MD771T000000001H7
Reference: MCL10703E
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 17.06.2026 01:59

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606452

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606452
Basic UDI-DI: 69268026MD771T000000001H7
Reference: MCL10702E
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 17.06.2026 01:59

Manufacturer products Authorised representative products Authorised representative actors View details