gudid Primary ID: MBD-AM-BB-2

Reliant(TM) Multistage Dilatation Balloon Catheter (UDI MBD-AM-BB-2)

Manufactured by Micro-Tech (Nanjing) Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Reliant(TM) Multistage Dilatation Balloon Catheter (Model/Catalog Number: MBD-AM-BB-2) is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FGE within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0237-2019 View Full Alert →

Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40...

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-1877-2018 View Full Alert →

Trident Endoscopic Ultrasonic Biopsy Needle (FNB)...

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-1878-2018 View Full Alert →

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)...

🔒 Compromised Lot & Serial Numbers Locked

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Technical Specifications

Model Number: MBD-AM-BB-2
Product Code / EMDN: FGE
Device Name: the balloon diameter is 6-7-8mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 2300mm,with stainless steel guide wire
Database Sync Date: 2026-08-09 09:22:01

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Reliant(TM) Multistage Dilatation Balloon Catheter?

The registered manufacturer of record for Reliant(TM) Multistage Dilatation Balloon Catheter is Micro-Tech (Nanjing) Co., Ltd..

What is the Primary UDI-DI identifier for Reliant(TM) Multistage Dilatation Balloon Catheter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MBD-AM-BB-2.

What classification code is assigned to this device?

This device is registered under product classification code FGE.

Similar Classification Devices (FGE)

Other Devices by Micro-Tech (Nanjing) Co., Ltd.

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