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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HCPPF-SN 3016Model HOMECATH Hydrophilic Urinary Catheter with Water Sachet PVC-Free Pediatric 30 CM 16 CH 30pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HOMECATH EUDAMED
- Device Name
- HOMECATH Hydrophilic Urinary Catheter with Water Sachet PVC-Free Pediatric 30 CM 16 CH EUDAMED
- Model / Reference
- HOMECATH Hydrophilic Urinary Catheter with Water Sachet PVC-Free Pediatric 30 CM 16 CH 30pcs/box EUDAMEDHCPPF-SN 3016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415740060 EUDAMED
- Basic UDI-DI
- B-18699415740060 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
A comprehensive medical device directory for the HOMECATH hydrophilic urinary catheter with water sachet, featuring advanced features and functionalities. Learn more about its regulatory compliance, market status, and FAQs.
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Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
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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-18699415740060 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED d3edd5f7-16f0-48a7-9bba-a56748aac47b 61 fields · synced Oct 7, 2026