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51 device results listed.

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EZ-PSA Professional PSA Test

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IVD Annex II List BNot specifiedOn the market

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059108156
Basic UDI-DI: B-00083059108156
Reference: 1081-15
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel® Prostate (PSA) Screening Test

1081-1

IVD Annex II List BIVDDOn the marketAnimal tissuesKitNear-patient testingSelf testingSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059108118
Basic UDI-DI: B-00083059108118
Reference: 1081-1
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231494
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HE-02B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231487
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HE-01B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231470
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HE-02
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231463
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HE-01
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231456
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HK-02B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231449
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HK-01B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231432
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HK-02
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:22

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

Prostate- Specific Antigen (PSA) Rapid Test

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231425
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HK-01
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.06.2026 01:21

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

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IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289810326
Basic UDI-DI: B-06933289810326
Reference: W230
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details