Accu-Chek Softclix (UDI 09917764001)
Manufactured by Roche Diagnostics Operations, Inc.
Device Regulatory Overview
The Accu-Chek Softclix (Model/Catalog Number: 09917764001) is a medical device manufactured by Roche Diagnostics Operations, Inc.. This product is indexed under FDA Product Code / Category Classification QRK within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 09917764001
- Product Code / EMDN
- QRK
- Device Name
- Accu-Chek Softclix Kit Canada
- Database Sync Date
- 2026-08-09 09:20:07
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 Accu-Chek Softclix?
The registered manufacturer of record for Accu-Chek Softclix is Roche Diagnostics Operations, Inc..
What is the Primary UDI-DI identifier for Accu-Chek Softclix?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09917764001.
What classification code is assigned to this device?
This device is registered under product classification code QRK.
Similar Classification Devices (QRK)
Other Devices by Roche Diagnostics Operations, Inc.
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