FDA.reportPublic FDA data

Youha

Primary DI
06972798250049
Brand
Youha
Company
Ningbo Youhe Mother And Baby Products Co., Ltd.
Model
YH-8015
Device description
The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.
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
K163136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163136000Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd.2017-07-31HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972798250046PackageGS112In Commercial Distribution
06972798250049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697279825004616972798250046
06972798250049069727982500496972798250049

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
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
06972798250162YOUHAYH-P8X2026-01-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900116FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900123FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900130FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
00020451906065Pump In Style Pro+ w/HarmonyMedela LLCHGX2026-07-20
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00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131056Willow Sync 24mm FlangesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131063Willow Sync Tubing AssemblyWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131087Willow Sync Receiver ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131094Willow Sync Replacement PumpWILLOW INNOVATIONS, INC.HGX2026-07-16
00879388005132Rumble TuffA Cute Baby IncHGX2026-07-05
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26973493592834Figaroo™ EaseShenzhen TPH Technology Co., LtdHGX2026-06-22
08809444071049HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071056HaenimHaenim Co.,Ltd.HGX2026-06-05