GUDIDData
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eudamed_udi Primary ID: 06970167440404

NeuViz ACE 64e (UDI 06970167440404)

Manufactured by Neusoft Medical Systems Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NeuViz ACE 64e - Primary ID 06970167440404

Device Regulatory Overview

The NeuViz ACE 64e (Model/Catalog Number: none) is a medical device manufactured by Neusoft Medical Systems Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z11030605 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-1650-2016 View Full Alert →

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0876-2017 View Full Alert →

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0875-2017 View Full Alert →

NeuViz 64 Multi-slice CT Scanner Systems...

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

Technical Specifications

Model Number
none
Product Code / EMDN
Z11030605
Device Name
MULTI-SLICE CT SCANNER SYSTEM
Database Sync Date
2026-08-09 17:39:07

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 NeuViz ACE 64e?

The registered manufacturer of record for NeuViz ACE 64e is Neusoft Medical Systems Co., Ltd..

What is the Primary UDI-DI identifier for NeuViz ACE 64e?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970167440404.

What classification code is assigned to this device?

This device is registered under product classification code Z11030605.

Similar Classification Devices (Z11030605)

Other Devices by Neusoft Medical Systems Co., Ltd.

Programmatic Export

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