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92 device results listed.

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Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760113
Basic UDI-DI: B-06971348760113
Reference: MF-47-20
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (CLIA)

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047935
Basic UDI-DI: 69449040AB740000156
Reference: 105-004245-00
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Free PSA Calibrators

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048284
Basic UDI-DI: 69449040AB740000156
Reference: 105-004287-00
EMDN: W0102030114
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

03770024321210

FPSA-RIACT

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321210
Basic UDI-DI: B-03770024321210
Reference: FPSA-RIACT
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

ichroma™ Free PSA

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043745
Basic UDI-DI: 880613303018CB
Reference: CFPC-178
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ FPSA

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404434
Basic UDI-DI: 69713904301047F
Reference: 010104001
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606476

Free PSA (CLIA)

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606476
Basic UDI-DI: 69268026MD771U000000001J4
Reference: MCL10801E
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06973864381810

2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests

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

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864381810
Basic UDI-DI: 6973864380084F4
Reference: 12010108823
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

06973864381803

2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests

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

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864381803
Basic UDI-DI: 6973864380084F4
Reference: 12010108821
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

06973864381797

2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests

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

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864381797
Basic UDI-DI: 6973864380084F4
Reference: 12010108822
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

06973864381780

2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests

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

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864381780
Basic UDI-DI: 6973864380084F4
Reference: 12010108820
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX f-PSA CMIA