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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HCT-SN 4012Model HOMECATH Hydrophilic Urinary Catheter with Water Sachet Tiemann 40 CM 12 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 Tiemann 40 CM 12 CH EUDAMED
- Model / Reference
- HOMECATH Hydrophilic Urinary Catheter with Water Sachet Tiemann 40 CM 12 CH 30pcs/box EUDAMEDHCT-SN 4012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18698703332604 EUDAMED
- Basic UDI-DI
- B-18698703332604 EUDAMED
- EMDN Code
- U01010601 TIEMANN 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-18698703332604 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 5c0ecadf-017e-4953-8333-ad85b66ddefc 61 fields · synced Oct 5, 2026