GUDIDData
eudamed_udi Primary ID: 06972820960977

SP5310E (UDI 06972820960977)

Manufactured by Shenzhen SINO-K Medical Technology Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SP5310E - Primary ID 06972820960977

Device Regulatory Overview

The SP5310E (Model/Catalog Number: 07-10-00) is a medical device manufactured by Shenzhen SINO-K Medical Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification C900301 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
07-10-00
Product Code / EMDN
C900301
Device Name
SPO2 Sensor
Database Sync Date
2026-08-09 18:56:50

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 SP5310E?

The registered manufacturer of record for SP5310E is Shenzhen SINO-K Medical Technology Co., Ltd..

What is the Primary UDI-DI identifier for SP5310E?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06972820960977.

What classification code is assigned to this device?

This device is registered under product classification code C900301.

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