gudid
Primary ID: U4 BLUE
EQUILIBRATORE U4 (UDI U4 BLUE)
Manufactured by EPTAMED SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EQUILIBRATORE U4 - Primary ID U4 BLUE
Device Regulatory Overview
The EQUILIBRATORE U4 (Model/Catalog Number: U4 BLUE) is a medical device manufactured by EPTAMED SRL. This product is indexed under FDA Product Code / Category Classification KMY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- U4 BLUE
- Product Code / EMDN
- KMY
- Device Name
- Preformed orthodontic tooth positioner
- Database Sync Date
- 2026-08-09 09:00:28
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 EQUILIBRATORE U4?
The registered manufacturer of record for EQUILIBRATORE U4 is EPTAMED SRL.
What is the Primary UDI-DI identifier for EQUILIBRATORE U4?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U4 BLUE.
What classification code is assigned to this device?
This device is registered under product classification code KMY.
Similar Classification Devices (KMY)
Other Devices by EPTAMED SRL
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