gudid Primary ID: CF165-B

Ensure(TM) Single-Use Coagulation Forceps (UDI CF165-B)

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 Ensure(TM) Single-Use Coagulation Forceps (Model/Catalog Number: CF165-B) is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification KGE 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: CF165-B
Product Code / EMDN: KGE
Device Name: The product should be stored in a cool, dry, clean, well-ventilated, non-corrosive gas environment. Do not expose the package to organic solvent, ionizing radiation or ultraviolet radiation.
Database Sync Date: 2026-08-09 09:24:49

Full Regulatory Attributes

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{
    "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 Ensure(TM) Single-Use Coagulation Forceps?

The registered manufacturer of record for Ensure(TM) Single-Use Coagulation Forceps is Micro-Tech (Nanjing) Co., Ltd..

What is the Primary UDI-DI identifier for Ensure(TM) Single-Use Coagulation Forceps?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CF165-B.

What classification code is assigned to this device?

This device is registered under product classification code KGE.

Similar Classification Devices (KGE)

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

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