gudid Primary ID: rev 01

Balloon Inflation Device (UDI rev 01)

Manufactured by BrosMed Medical Co.,Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Balloon Inflation Device (Model/Catalog Number: rev 01) is a medical device manufactured by BrosMed Medical Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification PTM within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0963-2019 View Full Alert →

Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemor...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: rev 01
Product Code / EMDN: PTM
Device Name
Database Sync Date: 2026-08-09 09:04:50

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 Balloon Inflation Device?

The registered manufacturer of record for Balloon Inflation Device is BrosMed Medical Co.,Ltd..

What is the Primary UDI-DI identifier for Balloon Inflation Device?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is rev 01.

What classification code is assigned to this device?

This device is registered under product classification code PTM.

Similar Classification Devices (PTM)

Other Devices by BrosMed Medical Co.,Ltd.

Programmatic Export

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

JSON API Endpoint