Strep B Rapid Test (UDI 06974566302899)
Manufactured by Zhuhai Encode Medical Engineering Co., Ltd.
Device Regulatory Overview
The Strep B Rapid Test (Model/Catalog Number: ISB-502) is a medical device manufactured by Zhuhai Encode Medical Engineering Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105011101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ISB-502
- Product Code / EMDN
- W0105011101
- Device Name
- Strep B Rapid Test
- Database Sync Date
- 2026-08-09 16:46:16
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Strep B Rapid Test?
The registered manufacturer of record for Strep B Rapid Test is Zhuhai Encode Medical Engineering Co., Ltd..
What is the Primary UDI-DI identifier for Strep B Rapid Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974566302899.
What classification code is assigned to this device?
This device is registered under product classification code W0105011101.
Similar Classification Devices (W0105011101)
Other Devices by Zhuhai Encode Medical Engineering Co., Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint