GUDIDData
eudamed_udi Primary ID: 06945630117138

ONETOUCH UltraSoft (UDI 06945630117138)

Manufactured by Sterilance Medical (Suzhou) Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ONETOUCH UltraSoft - Primary ID 06945630117138

Device Regulatory Overview

The ONETOUCH UltraSoft (Model/Catalog Number: 01-0130 Soft 30G) is a medical device manufactured by Sterilance Medical (Suzhou) Inc.. This product is indexed under FDA Product Code / Category Classification V010402 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
01-0130 Soft 30G
Product Code / EMDN
V010402
Device Name
Disposable Blood Lancets
Database Sync Date
2026-08-09 16:44:52

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 ONETOUCH UltraSoft?

The registered manufacturer of record for ONETOUCH UltraSoft is Sterilance Medical (Suzhou) Inc..

What is the Primary UDI-DI identifier for ONETOUCH UltraSoft?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06945630117138.

What classification code is assigned to this device?

This device is registered under product classification code V010402.

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