eudamed_udi
Primary ID: 08800036220128
Unspecified Brand (UDI 08800036220128)
Manufactured by Biotem Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 08800036220128
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: FXBR5010TS) is a medical device manufactured by Biotem Co., Ltd.. This product is indexed under FDA Product Code / Category Classification P01020101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FXBR5010TS
- Product Code / EMDN
- P01020101
- Device Name
- FXBR5010TS
- Database Sync Date
- 2026-08-09 16:28:46
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 Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is Biotem Co., Ltd..
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800036220128.
What classification code is assigned to this device?
This device is registered under product classification code P01020101.
Similar Classification Devices (P01020101)
Other Devices by Biotem Co., Ltd.
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