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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HNCF 1516Model HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 16 CH 40pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HOMECATH EUDAMED
- Device Name
- HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 16 CH EUDAMED
- Model / Reference
- HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 16 CH 40pcs/box EUDAMEDHNCF 1516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699415730866 EUDAMED
- Basic UDI-DI
- B-08699415730866 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
The HOMECATH Nelaton Urinary Catheter Pediatric 15 CM 16 CH device is a high-quality, FDA-cleared solution for the management of urinary retention and other pediatric urological conditions. Utilizing advanced material technology, this device provides reliable and consistent performance, ensuring accurate patient outcomes.
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-08699415730866 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 17195db2-9fa5-43ec-9254-ad4d85faa767 61 fields · synced Oct 7, 2026