eudamed_udi
Primary ID: 06930251802853
SEM 28 (867.04)(AD-2128) (UDI 06930251802853)
Manufactured by Andon Health Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SEM 28 (867.04)(AD-2128) - Primary ID 06930251802853
Device Regulatory Overview
The SEM 28 (867.04)(AD-2128) (Model/Catalog Number: AD-2128) is a medical device manufactured by Andon Health Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12062801 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- AD-2128
- Product Code / EMDN
- Z12062801
- Device Name
- Transcutaneous Electrical Nerve Stimulators (TENS Device)
- Database Sync Date
- 2026-08-09 16:50:14
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of SEM 28 (867.04)(AD-2128)?
The registered manufacturer of record for SEM 28 (867.04)(AD-2128) is Andon Health Co., Ltd..
What is the Primary UDI-DI identifier for SEM 28 (867.04)(AD-2128)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06930251802853.
What classification code is assigned to this device?
This device is registered under product classification code Z12062801.
Similar Classification Devices (Z12062801)
Other Devices by Andon Health Co., Ltd.
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