eudamed_udi
Primary ID: 08034108510828
ONDA (UDI 08034108510828)
Manufactured by DEKA M.E.L.A. SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ONDA - Primary ID 08034108510828
Device Regulatory Overview
The ONDA (Model/Catalog Number: M116A1) is a medical device manufactured by DEKA M.E.L.A. SRL. This product is indexed under FDA Product Code / Category Classification Z120608 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- M116A1
- Product Code / EMDN
- Z120608
- Device Name
- ONDA
- Database Sync Date
- 2026-08-09 16:44:58
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 ONDA?
The registered manufacturer of record for ONDA is DEKA M.E.L.A. SRL.
What is the Primary UDI-DI identifier for ONDA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08034108510828.
What classification code is assigned to this device?
This device is registered under product classification code Z120608.
Similar Classification Devices (Z120608)
Other Devices by DEKA M.E.L.A. SRL
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