gudid
Primary ID: H4
Headgear (UDI H4)
Manufactured by Suzhou Yuyue Medical Technology Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Headgear - Primary ID H4
Device Regulatory Overview
The Headgear (Model/Catalog Number: H4) is a medical device manufactured by Suzhou Yuyue Medical Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification BTK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- H4
- Product Code / EMDN
- BTK
- Device Name
- Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YF-02 & YN-03)
- Database Sync Date
- 2026-08-09 09:24:52
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 Headgear?
The registered manufacturer of record for Headgear is Suzhou Yuyue Medical Technology Co., Ltd..
What is the Primary UDI-DI identifier for Headgear?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is H4.
What classification code is assigned to this device?
This device is registered under product classification code BTK.
Similar Classification Devices (BTK)
Other Devices by Suzhou Yuyue Medical Technology Co., Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint