Identity
- Trade Name
- UltraCE Urine Prep EUDAMED
- Device Name
- UltraCE Urine Prep EUDAMED
- Model / Reference
- V130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056013025818 EUDAMED
- Basic UDI-DI
- 505601300ULTCEURPREPXK EUDAMED
- EMDN Code
- W0201050101 AUTOMATED ELECTROPHORESIS SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
UltraCE Urine Prep by Helena Biosciences Europe — 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 | 505601300ULTCEURPREPXK | Class A | Active |
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Manufacturer
- Manufacturer
- Helena Biosciences Europe
- EUDAMED SRN
- GB-MF-000028365
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED cc3df06f-e6ef-4473-be70-4beda448dbd9 61 fields · synced Oct 6, 2026