Identity
- Trade Name
- PROSYS LEG BAG WITH LEVER TAP NO GLOVES EUDAMED
- Device Name
- UROLOGY EUDAMED
- Model / Reference
- PH500S-LT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100010873 EUDAMED
- Basic UDI-DI
- 50361000U0017P EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prosys Leg Bag With Lever Tap No Gloves 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 | 50361000U0017P | 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 a3529c99-232a-4941-b3ae-100ea08ae08a 61 fields · synced Jun 19, 2026