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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HCMA 4016Model HOMECATH Antibacterial Hydrophilic Urinary Catheter Male 40 CM 16 CH 40pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HOMECATH EUDAMED
- Device Name
- HOMECATH Antibacterial Hydrophilic Urinary Catheter Male 40 CM 16 CH EUDAMED
- Model / Reference
- HOMECATH Antibacterial Hydrophilic Urinary Catheter Male 40 CM 16 CH 40pcs/box EUDAMEDHCMA 4016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415700057 EUDAMED
- Basic UDI-DI
- B-18699415700057 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-18699415700057 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED a0447f80-c90a-449e-9cf3-dcc9949de37d 61 fields · synced Oct 6, 2026