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227 device results listed.

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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

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

06979878281238

Fecal Occult Blood Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281238
Basic UDI-DI: B-06979878281238
Reference: 1001019
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:50

Manufacturer products Authorised representative products Authorised representative actors View details

06977903341322

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341322
Basic UDI-DI: B-06977903341322
Reference: GS110701C25
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

06977903341315

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341315
Basic UDI-DI: B-06977903341315
Reference: GS110701C01
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFOB Rapid Quantitative Test

25 servings/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565583542
Basic UDI-DI: B-06977565583542
Reference: 3542
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142646