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Prosys Flofit Self Adhesive Silicon Sheath-Std, 35mm
EUDAMEDClass I (EU MDR)
Ref PSS35STD/BRef PHF35S
Identity
- Trade Name
- Prosys Flofit Self Adhesive Silicon Sheath-Std,35mm EUDAMEDProsys Flofit Self Adhesive Silicon Sheath-Std, 35mm EUDAMED
- Device Name
- UROLOGY EUDAMED
- Model / Reference
- PSS35STD/B EUDAMEDPHF35S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100005770 EUDAMED05036100006319 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-Std, 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 a4faf5e9-9067-4f69-9d7a-6b9f0e76ef50 61 fields · synced Aug 4, 2026
- EUDAMED 15d2166e-dbb8-458f-8060-f92d87d7f49f 61 fields · synced May 18, 2026