gudid
Primary ID: YH-P8
YOUHA (UDI YH-P8)
Manufactured by Ningbo Youhe Mother And Baby Products Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for YOUHA - Primary ID YH-P8
Device Regulatory Overview
The YOUHA (Model/Catalog Number: YH-P8) is a medical device manufactured by Ningbo Youhe Mother And Baby Products Co., Ltd.. This product is indexed under FDA Product Code / Category Classification HGX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- YH-P8
- Product Code / EMDN
- HGX
- Device Name
- The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap:The pump is the core component of the electric breast pump. It generates a cyclic negative pressure(vacuum) to simulate a baby's sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump
- Database Sync Date
- 2026-08-09 09:06:41
Full Regulatory Attributes
🔒 Token Gated
{
"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 YOUHA?
The registered manufacturer of record for YOUHA is Ningbo Youhe Mother And Baby Products Co., Ltd..
What is the Primary UDI-DI identifier for YOUHA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is YH-P8.
What classification code is assigned to this device?
This device is registered under product classification code HGX.
Similar Classification Devices (HGX)
Other Devices by Ningbo Youhe Mother And Baby Products Co., Ltd.
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