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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

01.08.2026 06:24

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51 device results listed.

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CEA Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245295
Basic UDI-DI: B-15065026245295
Reference: TV20042
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel Prostate (PSA) Screening Test

1081-1

IVD Annex II List BIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: D-1081-1LS
Basic UDI-DI: B-1081-1LS
Reference: 1081-1
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 03:18

Manufacturer products View details

SOFTEC Creatine Kinase-MB Rapid Test Kit

SFCKMB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616299
Basic UDI-DI: B-08697962616299
Reference: SFCKMB
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

Simple PSA / Stick PSA

9.444.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577001616
Basic UDI-DI: B-08429577001616
Reference: 9.444.030.00.000
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:27

Manufacturer products View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190718
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402H-02
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190725
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402H-01B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190732
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402H-02B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190749
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HB-01
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190756
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HB-02
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190763
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HB-01B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190770
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HB-02B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190787
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HJ-01
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190794
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HJ-02
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190800
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HJ-01B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

-

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190817
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402HJ-02B
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Newfoundland Prostate Health test

IVD Annex II List BIVDDOn the marketKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164860084
Basic UDI-DI: B-07640164860084
Reference: 880080-1
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 07.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (f-PSA) Detection Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752132
Basic UDI-DI: B-06976374752132
Reference: 20 tests / kit（DR080-2）
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (t-PSA) Detection Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752125
Basic UDI-DI: B-06976374752125
Reference: 20 tests / kit（DR079-2）
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225916
Basic UDI-DI: B-06975424225916
Reference: DL248601C
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Assay Kit (Fluorescence Immunoassay)

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223516
Basic UDI-DI: B-06975424223516
Reference: DL248601
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details