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EUDAMED last updated this device on May 27, 2026
6970277510015EY7Prostate- Specific Antigen (PSA) Rapid Test is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936983190794TPS-NQ402HJ-02CN-MF-000010710EU-TDA-FI-51326-800081-2026(01)06936983190794
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Ireland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | — | Still on market |
| Croatia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160202PSA - RT & POCPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
V76 095123 0019SupplementedV76 095123 0020SupplementedEU-QMS-FI-08820-800081-2026IssuedEU-TDA-FI-51326-800081-2026IssuedEU-QMS-FI-08820-800081-2026IssuedCN26/00001622Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →6970277510015EY7On the marketProstate- Specific Antigen (PSA) Rapid Test6970277510015EY7On the marketProstate- Specific Antigen (PSA) Rapid Test6970277510015EY7On the marketProstate- Specific Antigen (PSA) Rapid Test6970277510015EY7On the marketProstate- Specific Antigen (PSA) Rapid Test6970277510015EY7On the marketProstate- Specific Antigen (PSA) Rapid Test6970277510015EY7On the market