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PRL Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320302802Model 25 Tests/Kit
Identity
- Trade Name
- PRL Test (FIA) EUDAMED
- Device Name
- PRL Test (FIA) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED0320302802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139071311 EUDAMED06978139075852 EUDAMED
- Basic UDI-DI
- B-06978139071311 EUDAMEDB-06978139075852 EUDAMED
- EMDN Code
- W0102050108 PROLACTIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
The PRL Test (FIA) is a medical device designed for the detection of prostate-specific antigen (PSA), a protein produced by the prostate gland. This test provides valuable information for diagnosing and managing prostate cancer, as well as monitoring prostate health in healthy individuals.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06978139071311 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED b118db3a-91ed-48b9-a267-202b30896a4f 61 fields · synced Jul 28, 2026
- EUDAMED b89d845d-a0a3-47e6-b6ad-9b53c8fb4a5e 61 fields · synced May 19, 2026