Identity
- Trade Name
- URI-TEX 300 EUDAMED
- Device Name
- URI - TEX 300 EUDAMED
- Model / Reference
- X-161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514601752 EUDAMED
- Basic UDI-DI
- 59075146Uritex300R3 EUDAMED
- EMDN Code
- W02010701 URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Uri-Tex 300 by PZ CORMAY Spółka Akcyjna — Class A — 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 | 59075146Uritex300R3 | Class A | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (1)
- EUDAMED e2f89c15-149a-42db-a3cd-51ad285f849c 61 fields · synced Jul 12, 2026