eudamed_udi
Primary ID: 08800111722028
STANDARD™ i PCT (UDI 08800111722028)
Manufactured by SD Biosensor Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for STANDARD™ i PCT - Primary ID 08800111722028
Device Regulatory Overview
The STANDARD™ i PCT (Model/Catalog Number: 16PCT10Q) is a medical device manufactured by SD Biosensor Inc.. This product is indexed under FDA Product Code / Category Classification W0102069013 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 16PCT10Q
- Product Code / EMDN
- W0102069013
- Device Name
- STANDARD™ i PCT
- Database Sync Date
- 2026-08-09 16:50:11
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 STANDARD™ i PCT?
The registered manufacturer of record for STANDARD™ i PCT is SD Biosensor Inc..
What is the Primary UDI-DI identifier for STANDARD™ i PCT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800111722028.
What classification code is assigned to this device?
This device is registered under product classification code W0102069013.
Similar Classification Devices (W0102069013)
Other Devices by SD Biosensor Inc.
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