eudamed_udi
Primary ID: 08697550621049
Manucare comfort (UDI 08697550621049)
Manufactured by Arden Medical
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Manucare comfort - Primary ID 08697550621049
Device Regulatory Overview
The Manucare comfort (Model/Catalog Number: 4515-M-Left) is a medical device manufactured by Arden Medical. This product is indexed under FDA Product Code / Category Classification Y060612 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 4515-M-Left
- Product Code / EMDN
- Y060612
- Device Name
- WRIST-HAND ORTHOSES
- Database Sync Date
- 2026-08-09 16:29:01
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 Manucare comfort?
The registered manufacturer of record for Manucare comfort is Arden Medical.
What is the Primary UDI-DI identifier for Manucare comfort?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08697550621049.
What classification code is assigned to this device?
This device is registered under product classification code Y060612.
Similar Classification Devices (Y060612)
Other Devices by Arden Medical
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