← Back to catalogue
Prosys Flofit Self Adhesive Silicon Sheath-W/Band, 31mm
EUDAMEDClass I (EU MDR)
Ref PHF31WRef PHF31W5
Identity
- Trade Name
- Prosys Flofit Self Adhesive Silicon Sheath-W/Band,31mm EUDAMEDProsys Flofit Self Adhesive Silicon Sheath-W/Band,31mm,5s EUDAMED
- Device Name
- UROLOGY EUDAMED
- Model / Reference
- PHF31W EUDAMEDPHF31W5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100006586 EUDAMED05036100027314 EUDAMED
- Basic UDI-DI
- 50361000U0017P EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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 Flofit Self Adhesive Silicon Sheath-W/Band, 31mm 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clinisupplies Ltd
- EUDAMED SRN
- GB-MF-000023783
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 480f5706-0307-4887-9c5a-61535a6604dd 61 fields · synced Jul 13, 2026
- EUDAMED 804ab03d-93f0-43dd-afd4-28aa2c286f5d 61 fields · synced May 18, 2026