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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HCIM 4016Model HOMECATH Hydrophilic Instillation 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 Hydrophilic Instillation Urinary Catheter Male 40 CM 16 CH EUDAMED
- Model / Reference
- HOMECATH Hydrophilic Instillation Urinary Catheter Male 40 CM 16 CH 40pcs/box EUDAMEDHCIM 4016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699415700821 EUDAMED
- Basic UDI-DI
- B-08699415700821 EUDAMED
- EMDN Code
- U1301 SOLUTIONS FOR BLADDER WASHING AND INSTILLATION 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-08699415700821 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED ff90c2f5-cce3-495a-9c25-519f316caaab 61 fields · synced Oct 6, 2026