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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HCF-RU 2010Model HOMECATH Hydrophilic Urinary Catheter -Ready To Use Female 20 CM 10 CH Aluminum Package 30pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HOMECATH EUDAMED
- Device Name
- HOMECATH Hydrophilic Urinary Catheter -Ready To Use Female 20 CM 10 CH Aluminum Package EUDAMED
- Model / Reference
- HOMECATH Hydrophilic Urinary Catheter -Ready To Use Female 20 CM 10 CH Aluminum Package 30pcs/box EUDAMEDHCF-RU 2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415733352 EUDAMED
- Basic UDI-DI
- B-18699415733352 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
Homecath by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — 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-18699415733352 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED ebd10798-dcfb-4f92-be3f-f59a1a5a9a45 61 fields · synced Oct 6, 2026