gudid
Primary ID: 66986885
Mondial 8i DS, B1 / 35 U, CE (UDI 66986885)
Manufactured by Kulzer GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Mondial 8i DS, B1 / 35 U, CE - Primary ID 66986885
Device Regulatory Overview
The Mondial 8i DS, B1 / 35 U, CE (Model/Catalog Number: 66986885) is a medical device manufactured by Kulzer GmbH. This product is indexed under FDA Product Code / Category Classification ELM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 66986885
- Product Code / EMDN
- ELM
- Device Name
- Denture, plastic, teeth
- Database Sync Date
- 2026-08-09 09:09:37
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 Mondial 8i DS, B1 / 35 U, CE?
The registered manufacturer of record for Mondial 8i DS, B1 / 35 U, CE is Kulzer GmbH.
What is the Primary UDI-DI identifier for Mondial 8i DS, B1 / 35 U, CE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 66986885.
What classification code is assigned to this device?
This device is registered under product classification code ELM.
Similar Classification Devices (ELM)
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