GUDIDData
Bulk Audit Tool API Access
gudid Primary ID: uMI Panvivo

uMI (UDI uMI Panvivo)

Manufactured by Shanghai United Imaging Healthcare Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for uMI - Primary ID uMI Panvivo

Device Regulatory Overview

The uMI (Model/Catalog Number: uMI Panvivo) is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. This product is indexed under FDA Product Code / Category Classification KPS 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-1708-2020 View Full Alert →

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI:...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2472-2020 View Full Alert →

uCT 530 Computed Tomography X-Ray System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2704-2020 View Full Alert →

Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional im...

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

Technical Specifications

Model Number
uMI Panvivo
Product Code / EMDN
KPS
Device Name
Positron Emission Tomography and Computed Tomography System
Database Sync Date
2026-08-09 09:06:43

Full Regulatory Attributes

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

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Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

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Frequently Asked Questions

Who is the primary manufacturer of uMI?

The registered manufacturer of record for uMI is Shanghai United Imaging Healthcare Co., Ltd..

What is the Primary UDI-DI identifier for uMI?

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

What classification code is assigned to this device?

This device is registered under product classification code KPS.

Similar Classification Devices (KPS)

Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

Programmatic Export

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

JSON API Endpoint