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04560189211612

ST AIA-PACK PSAII SAMPLE DILUTING SOLUTION

IVD Annex II List BIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211612
Basic UDI-DI: B-04560189211612
Reference: 0025512
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211605

ST AIA-PACK PSAII CALIBRATOR SET

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211605
Basic UDI-DI: B-04560189211605
Reference: 0025312
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

CanAg PSA EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140173
Basic UDI-DI: 73500661401799
Reference: 340-10
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

Manufacturer products View details

Total Prostate Specific Antigen test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404876
Basic UDI-DI: 697029753068LL
Reference: HGCL24
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

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: 06942359548397
Basic UDI-DI: 697015090000111GS
Reference: CMB0303
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen(CLIA)

105-004219-00、105-004246-00、105-004288-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047737
Basic UDI-DI: 69449040004H-t-PSA*****H9
Reference: 105-004219-00
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Total PSA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715917
Basic UDI-DI: 692591270097HS
Reference: C86000-L
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S Total PSA KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631908
Basic UDI-DI: 426015763810BTotaPSAKXXHJ
Reference: 810100N
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

PSA total IRMA KIT

Immunoassay IM1950

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216207
Basic UDI-DI: 150995905IM19506A
Reference: IM1950
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

Access Hybritech PSA (Sample Diluent)

37206

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232351
Basic UDI-DI: 150995901AccHPSASamDilY7
Reference: 37206
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

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

PSA-XS AccuLite CLIA Kit - 96 Wells

8775-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022314
Basic UDI-DI: 081687002PSAXS8775FK
Reference: 8775-300A
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

PSA-XS AccuBind ELISA Kit - 96 Well

8725-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020631
Basic UDI-DI: 081687002PSAXS8725F4
Reference: 8725-300A
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

AFP, CEA & PSA AccuBind VAST ELISA Kit - 192 wells

8425-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

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

Manufacturer products Authorised representative products Authorised representative actors View details