eudamed_udi
Primary ID: EPRCA0033004
otosil ES-1.1 (UDI EPRCA0033004)
Manufactured by pro3dure medical GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for otosil ES-1.1 - Primary ID EPRCA0033004
Device Regulatory Overview
The otosil ES-1.1 (Model/Catalog Number: A0033004) is a medical device manufactured by pro3dure medical GmbH. This product is indexed under FDA Product Code / Category Classification Y214580 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- A0033004
- Product Code / EMDN
- Y214580
- Device Name
- 12140202
- Database Sync Date
- 2026-08-09 16:29:02
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 otosil ES-1.1?
The registered manufacturer of record for otosil ES-1.1 is pro3dure medical GmbH.
What is the Primary UDI-DI identifier for otosil ES-1.1?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is EPRCA0033004.
What classification code is assigned to this device?
This device is registered under product classification code Y214580.
Similar Classification Devices (Y214580)
Other Devices by pro3dure medical GmbH
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