GUDIDData
gudid Primary ID: EUS-22-0-CS2

Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) (UDI EUS-22-0-CS2)

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

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) - Primary ID EUS-22-0-CS2

Device Regulatory Overview

The Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) (Model/Catalog Number: EUS-22-0-CS2) is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification ODG 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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Unlock Lot Data ($49)
ID: Z-1878-2018 View Full Alert →

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
EUS-22-0-CS2
Product Code / EMDN
ODG
Device Name
Maximum insertion portion diameter:1.8mm,Needle:22G,Maximum needle length:80mm,Working channel: Greater than or equal to 2.8mm,Working Length:1245~1285mm, FNA needle
Database Sync Date
2026-08-09 09:24:49

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 Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)?

The registered manufacturer of record for Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) is Micro-Tech (Nanjing) Co., Ltd..

What is the Primary UDI-DI identifier for Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is EUS-22-0-CS2.

What classification code is assigned to this device?

This device is registered under product classification code ODG.

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