eudamed_udi
Primary ID: 08800012322013
Hi-bebe S (UDI 08800012322013)
Manufactured by Bistos Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Hi-bebe S - Primary ID 08800012322013
Device Regulatory Overview
The Hi-bebe S (Model/Catalog Number: BT-220C) is a medical device manufactured by Bistos Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12080103 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BT-220C
- Product Code / EMDN
- Z12080103
- Device Name
- Ultrasound Doppler system with Probes
- Database Sync Date
- 2026-08-09 17:55:29
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 Hi-bebe S?
The registered manufacturer of record for Hi-bebe S is Bistos Co., Ltd..
What is the Primary UDI-DI identifier for Hi-bebe S?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800012322013.
What classification code is assigned to this device?
This device is registered under product classification code Z12080103.
Similar Classification Devices (Z12080103)
Other Devices by Bistos Co., Ltd.
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