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FREND PSA Plus
EUDAMEDFDA 510(k)FDA UDIClass IVD Annex II List B (EU MDR)
Ref FRPS 025Model FREND PSA Plus510(k) K162378
Identity
- Trade Name
- FREND PSA Plus EUDAMEDFDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- FRPS 025 EUDAMEDIt is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System. FDA UDI
- Model / Reference
- FREND PSA Plus EUDAMEDFRPS 025 EUDAMEDFDA UDI
- Description
- It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System. FDA UDI
Identifiers
- Catalog Number
- FRPS 025 FDA UDI
- Primary DI / UDI-DI
- 08809317540481 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540481 EUDAMED
- 510(k) Number
- K162378 FDA 510(k)
- FDA Product Code
- LTJ FDA 510(k)FDA UDI
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.6010 FDA 510(k)
- Regulation Number
- 866.6010 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FREND PSA Plus by NanoEnTek, Inc. — Class IVD Annex II List B — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162378 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-08809317540481 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED f9c5c6a6-007c-430c-9ce5-580e9180167f 61 fields · synced Jul 11, 2026
- FDA 510(k) K162378 24 fields · synced May 18, 2026
- FDA UDI 19af3bc8-1f05-4d60-8ebb-c897090453cf 34 fields · synced May 30, 2026
- EUDAMED 14055110-fbc5-4294-8cb5-4f02a2cf320b 61 fields · synced Jul 11, 2026