gudid
Primary ID: 8150
OTI (UDI 8150)
Manufactured by Xiamen Oti Electronic Industry Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OTI - Primary ID 8150
Device Regulatory Overview
The OTI (Model/Catalog Number: 8150) is a medical device manufactured by Xiamen Oti Electronic Industry Co., Ltd.. This product is indexed under FDA Product Code / Category Classification BTK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 8150
- Product Code / EMDN
- BTK
- Device Name
- face mask Headstrap
- Database Sync Date
- 2026-08-09 09:18:20
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 OTI?
The registered manufacturer of record for OTI is Xiamen Oti Electronic Industry Co., Ltd..
What is the Primary UDI-DI identifier for OTI?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8150.
What classification code is assigned to this device?
This device is registered under product classification code BTK.
Similar Classification Devices (BTK)
Other Devices by Xiamen Oti Electronic Industry Co., Ltd.
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