gudid
Primary ID: BC1 Bone Conductor
3000 Real Ear (UDI BC1 Bone Conductor)
Manufactured by Auditdata A/S
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 3000 Real Ear - Primary ID BC1 Bone Conductor
Device Regulatory Overview
The 3000 Real Ear (Model/Catalog Number: BC1 Bone Conductor) is a medical device manufactured by Auditdata A/S. This product is indexed under FDA Product Code / Category Classification EWO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BC1 Bone Conductor
- Product Code / EMDN
- EWO
- Device Name
- BC1 Bone Conductor (2000-1)
- Database Sync Date
- 2026-08-09 09:12:44
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 3000 Real Ear?
The registered manufacturer of record for 3000 Real Ear is Auditdata A/S.
What is the Primary UDI-DI identifier for 3000 Real Ear?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BC1 Bone Conductor.
What classification code is assigned to this device?
This device is registered under product classification code EWO.
Similar Classification Devices (EWO)
Other Devices by Auditdata A/S
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