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Camstent BACTERIA-PHOBIC® Coated Foley Catheter
EUDAMEDClass IIa (EU MDR)
Ref CSF14F10Ref CSF18S10Ref CSF12F10
by Camstent Ltd
Identity
- Device Name
- Camstent BACTERIA-PHOBIC® Coated Foley Catheter EUDAMED
- Model / Reference
- CSF14F10 EUDAMEDCSF18S10 EUDAMEDCSF12F10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060718070110 EUDAMED05060718070042 EUDAMED05060718070004 EUDAMED
- Basic UDI-DI
- B-05060718070110 EUDAMEDB-05060718070042 EUDAMEDB-05060718070004 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Camstent BACTERIA-PHOBIC® Coated Foley Catheter by Camstent Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060718070110 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Camstent Ltd
- EUDAMED SRN
- GB-MF-000012349
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (3)
- EUDAMED 1ebd875e-8602-4411-a5b4-93cd72cc5f4a 61 fields · synced Jul 23, 2026
- EUDAMED 5b5a187b-1e5b-4976-9b17-771b5ff2e6c4 61 fields · synced May 19, 2026
- EUDAMED 3e016a37-edf6-488e-8daf-01a3fca36478 61 fields · synced May 19, 2026