Identity
- Trade Name
- CliniSure Urinary Sheath Pop on 35mm EUDAMED
- Device Name
- CliniSure Urinary Sheath EUDAMED
- Model / Reference
- CS35P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05017950000245 EUDAMED
- Basic UDI-DI
- 5017950CliniSureSheathMJ EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
CliniSure Urinary Sheath Pop on 35mm by CliniMed Limited — 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 | 5017950CliniSureSheathMJ | Class I | Active |
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Manufacturer
- Manufacturer
- CliniMed Limited
- EUDAMED SRN
- GB-MF-000023784
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED c5688305-edd4-4246-ba10-8f5061cd1ec0 61 fields · synced Jul 9, 2026