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Homecath
EUDAMEDClass IIa (EU MDR)
Ref HCM-RU 4012Model HOMECATH Hydrophilic Urinary Catheter -Ready To Use Male 40 CM 12 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 Male 40 CM 12 CH Aluminum Package EUDAMED
- Model / Reference
- HOMECATH Hydrophilic Urinary Catheter -Ready To Use Male 40 CM 12 CH Aluminum Package 30pcs/box EUDAMEDHCM-RU 4012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415732904 EUDAMED
- Basic UDI-DI
- B-18699415732904 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
Introducing the HOMECATH Hydrophilic Urinary Catheter -Ready To Use Male 40 CM 12 CH Aluminum Package, a cutting-edge medical device designed for comfortable and safe urine drainage. With its innovative design, advanced sterilization process, and user-friendly interface, the HOMECATH is perfect for patients requiring long-term urinary catheterization.
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-18699415732904 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED dd530a1d-08e5-4907-981b-11da1d25c791 61 fields · synced Oct 7, 2026