eudamed_udi Primary ID: 08032248474086

Double-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96, L=300mm) (UDI 08032248474086)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Double-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96, L=300mm) (Model/Catalog Number: MBP4641M) is a medical device manufactured by Delta Med SPA. This product is indexed under FDA Product Code / Category Classification U050402 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MBP4641M
Product Code / EMDN: U050402
Device Name: Rectal Catheters
Database Sync Date: 2026-08-09 17:37:13

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 Double-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96, L=300mm)?

The registered manufacturer of record for Double-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96, L=300mm) is Delta Med SPA.

What is the Primary UDI-DI identifier for Double-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96, L=300mm)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08032248474086.

What classification code is assigned to this device?

This device is registered under product classification code U050402.

Similar Classification Devices (U050402)

Other Devices by Delta Med SPA

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint