eudamed_udi
Primary ID: 04719893347234
WiZARD 520 (UDI 04719893347234)
Manufactured by Wellell Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for WiZARD 520 - Primary ID 04719893347234
Device Regulatory Overview
The WiZARD 520 (Model/Catalog Number: SM12002) is a medical device manufactured by Wellell Inc.. This product is indexed under FDA Product Code / Category Classification R0301010201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SM12002
- Product Code / EMDN
- R0301010201
- Device Name
- Full Face Mask
- Database Sync Date
- 2026-08-09 16:30:13
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 WiZARD 520?
The registered manufacturer of record for WiZARD 520 is Wellell Inc..
What is the Primary UDI-DI identifier for WiZARD 520?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04719893347234.
What classification code is assigned to this device?
This device is registered under product classification code R0301010201.
Similar Classification Devices (R0301010201)
Other Devices by Wellell Inc.
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