gudid Primary ID: ST8001-1

BioTeke (UDI ST8001-1)

Manufactured by Bioteke Corporation (Wuxi) Co., Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The BioTeke (Model/Catalog Number: ST8001-1) is a medical device manufactured by Bioteke Corporation (Wuxi) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification JSG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ST8001-1
Product Code / EMDN: JSG
Device Name
Database Sync Date: 2026-08-09 09:06:38

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 BioTeke?

The registered manufacturer of record for BioTeke is Bioteke Corporation (Wuxi) Co., Ltd..

What is the Primary UDI-DI identifier for BioTeke?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ST8001-1.

What classification code is assigned to this device?

This device is registered under product classification code JSG.

Similar Classification Devices (JSG)

Other Devices by Bioteke Corporation (Wuxi) Co., Ltd.

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