Identity
- Trade Name
- Ultra-Low PSA Control (UL PSA Control) EUDAMED
- Device Name
- Ultra-Low PSA Control (UL PSA Control) EUDAMED
- Model / Reference
- TU10523 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273218787 EUDAMED
- Basic UDI-DI
- 50552732CULOPSA062XC EUDAMED
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
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
New Device
No
EUDAMED
Ultra-Low PSA Control (UL PSA Control) by Randox Laboratories Limited — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732CULOPSA062XC | Class C | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 202f5f1d-bd59-4ab0-8c4e-fcf4d248b11f 61 fields · synced Jul 9, 2026