eudamed_udi
Primary ID: 08809661400028
ULTRA 100 (UDI 08809661400028)
Manufactured by ECORAY Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ULTRA 100 - Primary ID 08809661400028
Device Regulatory Overview
The ULTRA 100 (Model/Catalog Number: EBF-U10-001) is a medical device manufactured by ECORAY Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z11039016 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- EBF-U10-001
- Product Code / EMDN
- Z11039016
- Device Name
- ULTRA 100
- Database Sync Date
- 2026-08-09 17:47:55
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 ULTRA 100?
The registered manufacturer of record for ULTRA 100 is ECORAY Co., Ltd..
What is the Primary UDI-DI identifier for ULTRA 100?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08809661400028.
What classification code is assigned to this device?
This device is registered under product classification code Z11039016.
Similar Classification Devices (Z11039016)
Other Devices by ECORAY Co., Ltd.
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