HOMECATH (UDI 18699415725456)
Manufactured by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Device Regulatory Overview
The HOMECATH (Model/Catalog Number: HCMPF 4018) is a medical device manufactured by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi. This product is indexed under FDA Product Code / Category Classification U01010501 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HCMPF 4018
- Product Code / EMDN
- U01010501
- Device Name
- HOMECATH Hydrophilic Urinary Catheter PVC-Free Male 40 CM 18 CH
- Database Sync Date
- 2026-08-09 16:29:15
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of HOMECATH?
The registered manufacturer of record for HOMECATH is İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi.
What is the Primary UDI-DI identifier for HOMECATH?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 18699415725456.
What classification code is assigned to this device?
This device is registered under product classification code U01010501.
Similar Classification Devices (U01010501)
Other Devices by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint