HOKAPI™ HER-2/NEU (UDI 06971390439746)
Manufactured by Suzhou Hokapi Biomedical Engineering Co., Ltd..
Device Regulatory Overview
The HOKAPI™ HER-2/NEU (Model/Catalog Number: 010123101) is a medical device manufactured by Suzhou Hokapi Biomedical Engineering Co., Ltd... This product is indexed under FDA Product Code / Category Classification W0102030301 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 010123101
- Product Code / EMDN
- W0102030301
- Device Name
- HOKAPI™ HER-2/NEU
- Database Sync Date
- 2026-08-09 17:06:46
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 HOKAPI™ HER-2/NEU?
The registered manufacturer of record for HOKAPI™ HER-2/NEU is Suzhou Hokapi Biomedical Engineering Co., Ltd...
What is the Primary UDI-DI identifier for HOKAPI™ HER-2/NEU?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06971390439746.
What classification code is assigned to this device?
This device is registered under product classification code W0102030301.
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