YOUHA

Primary DI
06972798250162
Brand
YOUHA
Company
Ningbo Youhe Mother And Baby Products Co., Ltd.
Model
YH-P8X
Device description
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
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251977000electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)Ningbo Youhe Electrical Appliance Technology Co., Ltd.2025-10-22HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972798250169PackageGS112In Commercial Distribution
06972798250162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697279825016916972798250169
06972798250162069727982501626972798250162

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Regulatory Flags#

DUNS number
412923842
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972798250025YouhaYH-80162026-01-07
06972798250049YouhaYH-80152026-01-07
06972798250056YouhaTHE ONE2026-01-07
06972798250063YouhaYH-80112026-01-07
06972798250070YouhaYH-80122026-01-07
06972798250087YouhaYH-80192026-01-07
06972798250100YiyadodoYY-50302026-01-07
06972798250117BebebaoP32026-01-07
06972798250124BebebaoP1s2026-01-07
06972798250131YOUHATHe INs Gen 22026-01-07
06972798250148YOUHAThe INs2026-01-07
06972798250155YOUHAThe INs NEXT2026-01-07
06972798250186YOUHAFZ-P82026-01-07
16972798250022YouhaYH-80162026-01-07
06972798250032YouhaYH-8006IV2026-01-07
16972798250046YouhaYH-80152026-01-07
16972798250053YouhaTHE ONE2026-01-07
16972798250060YouhaYH-80112026-01-07
16972798250077YouhaYH-80122026-01-07
16972798250084YouhaYH-80192026-01-07

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