Zhende SG-WR (UDI ZD23104K)
Manufactured by Xuchang Zhengde Environstar Medical Products Co., Ltd.
Device Regulatory Overview
The Zhende SG-WR (Model/Catalog Number: ZD23104K) is a medical device manufactured by Xuchang Zhengde Environstar Medical Products Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FYA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ZD23104K
- Product Code / EMDN
- FYA
- Device Name
- Surgical Gown With Reinforcement, XXL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton
- Database Sync Date
- 2026-08-09 09:06:45
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 Zhende SG-WR?
The registered manufacturer of record for Zhende SG-WR is Xuchang Zhengde Environstar Medical Products Co., Ltd..
What is the Primary UDI-DI identifier for Zhende SG-WR?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ZD23104K.
What classification code is assigned to this device?
This device is registered under product classification code FYA.
Similar Classification Devices (FYA)
Other Devices by Xuchang Zhengde Environstar Medical Products Co., Ltd.
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