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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

CA242 (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064314
Basic UDI-DI: 69703416803205100HY
Reference: 0320510701
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

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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

Free PSA AccuLite CLIA Kit - 96 wells

2375-300

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

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022277
Basic UDI-DI: 081687002FPSA2375J8
Reference: 2375-300A
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

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CEA NEXT GEN AccuLite CLIA Kit - 96 wells

4675-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022239
Basic UDI-DI: 081687002CEANG4675LL
Reference: 4675-300A
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

CA 15-3 AccuLite CLIA Kit - 96 wells

5675-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022178
Basic UDI-DI: 081687002CA1535675S4
Reference: 5675-300A
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

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CA-125 AccuLite CLIA Kit - 96 wells

3075-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022154
Basic UDI-DI: 081687002CA1253075Q7
Reference: 3075-300A
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

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AFP, CEA & PSA AccuLite VAST CLIA Kit - 192 wells

8475-300

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

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022109
Basic UDI-DI: 081687002PSAVAST84752H
Reference: 8475-300B
EMDN: W0102030122
EMDN description: EARLY PROSTATE CANCER ANTIGEN - 2
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

Free PSA AccuBind ELISA Kit - 96 wells

2325-300

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

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020594
Basic UDI-DI: 081687002FPSA2325HR
Reference: 2325-300A
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

CEA NEXT GEN AccuBind ELISA Kit - 96 wells

4625-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020556
Basic UDI-DI: 081687002CEANG4625L5
Reference: 4625-300A
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

CA 19-9 AccuBind ELISA Kit - 96 wells

3925-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020518
Basic UDI-DI: 081687002CA1993925VC
Reference: 3925-300A
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

CA 15-3 Accubind ELISA Kit - 96 wells

5625-300

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020495
Basic UDI-DI: 081687002CA1535625RM
Reference: 5625-300A
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 16.07.2026 04:22

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

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 fPSA

IVDR_67_TTN_DUB-C_C_KIT_Free Prostate-Specific Antigen

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414553344
Basic UDI-DI: 0405686901812VR
Reference: 10283414
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details