Identity
- Trade Name
- Prosys Urine meters EUDAMED
- Device Name
- Urine meter EUDAMED
- Model / Reference
- P400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100010125 EUDAMED
- Basic UDI-DI
- 50361000M0015X EUDAMED
- EMDN Code
- A06030302 HOURLY DIURESIS MEASUREMENT SETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prosys Urine meters by Clinisupplies Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50361000M0015X | Class I | Active |
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Manufacturer
- Manufacturer
- Clinisupplies Ltd
- EUDAMED SRN
- GB-MF-000023783
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 55bb94a0-1016-4801-be4e-3ee42cbd450f 61 fields · synced Jul 9, 2026