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Urea
EUDAMEDClass B (EU MDR)
Ref URSL-5M30Ref URSL-0420Ref URSL-6605Ref URSL-6255Ref URSL-M830Ref URSL-6M10
Identity
- Trade Name
- UREA EUDAMEDUREA UV SL EUDAMED
- Device Name
- UREA EUDAMEDUREA UV SL EUDAMED
- Model / Reference
- URSL-5M30 EUDAMEDURSL-0420 EUDAMEDURSL-6605 EUDAMEDURSL-6255 EUDAMEDURSL-M830 EUDAMEDURSL-6M10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700807216 EUDAMED03701700827504 EUDAMED03701700827726 EUDAMED03701700827528 EUDAMED03701700807209 EUDAMED03701700807223 EUDAMED
- Basic UDI-DI
- 37017008URSL01JW EUDAMED37017008URSL00JU EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Urea by Vitalscientific — Class B — 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 | 37017008URSL01JW | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (6)
- EUDAMED 1f9682b4-c73a-4251-964f-af61c211843d 61 fields · synced Jul 30, 2026
- EUDAMED 5771efaf-db5d-438d-bc56-822c50736355 61 fields · synced May 17, 2026
- EUDAMED 10a5a5ba-f588-46e5-9877-820cfb2389c0 61 fields · synced May 18, 2026
- EUDAMED ab8c7635-f720-4ebb-a50c-6c9c6f61d0a6 61 fields · synced May 18, 2026
- EUDAMED ba8f46e6-f5e0-48a9-8c68-caaa7c67590b 61 fields · synced May 18, 2026
- EUDAMED d7797388-5812-4260-bdd5-e6f39c18475d 61 fields · synced May 18, 2026