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Prosys Flofit Self Adhesive Silicon Sheathh-Std, 28mm
EUDAMEDClass I (EU MDR)
Ref PHF28S
Identity
- Trade Name
- Prosys Flofit Self Adhesive Silicon Sheathh-Std, 28mm EUDAMED
- Device Name
- UROLOGY EUDAMED
- Model / Reference
- PHF28S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100006258 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 Sheathh-Std, 28mm 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 ea3e601f-d344-4ec6-8289-bc5546a861bd 61 fields · synced Jun 19, 2026