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Prosys Flofit Self Adhesive Silicon Sheath-Pop on, 35mm
EUDAMEDClass I (EU MDR)
Ref PSS35POPON/BRef PHF35P
Identity
- Trade Name
- Prosys Flofit Self Adhesive Silicon Sheath-Pop on,35mm EUDAMED
- Device Name
- UROLOGY EUDAMED
- Model / Reference
- PSS35POPON/B EUDAMEDPHF35P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100005954 EUDAMED05036100006463 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-Pop on, 35mm 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 (2)
- EUDAMED 993e91be-3254-4e1e-806a-30f32f32194f 61 fields · synced Jul 11, 2026
- EUDAMED d72e26b0-3129-4c84-8c4f-07e9ef335ede 61 fields · synced May 18, 2026