eudamed_udi
Primary ID: 06970581431194
Accu-Tell® OPI Strip (Urine) (UDI 06970581431194)
Manufactured by AccuBioTech Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Accu-Tell® OPI Strip (Urine) - Primary ID 06970581431194
Device Regulatory Overview
The Accu-Tell® OPI Strip (Urine) (Model/Catalog Number: ABT-DOA-A161) is a medical device manufactured by AccuBioTech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160508 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ABT-DOA-A161
- Product Code / EMDN
- W0102160508
- Device Name
- Accu-Tell® OPI Test
- Database Sync Date
- 2026-08-09 17:25:35
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-Tell® OPI Strip (Urine)?
The registered manufacturer of record for Accu-Tell® OPI Strip (Urine) is AccuBioTech Co., Ltd..
What is the Primary UDI-DI identifier for Accu-Tell® OPI Strip (Urine)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970581431194.
What classification code is assigned to this device?
This device is registered under product classification code W0102160508.
Similar Classification Devices (W0102160508)
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