Youha

Primary DI
06972798250070
Brand
Youha
Company
Ningbo Youhe Mother And Baby Products Co., Ltd.
Model
YH-8012
Device description
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts)configurations. YY-8011 and YH-8019 have a single pumping configuration only.A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panelkeypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing
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
K203148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203148000Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)Ningbo Youhe Electrical Appliance Technology Co., Ltd.2021-07-08HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972798250077PackageGS112In Commercial Distribution
06972798250070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697279825007716972798250077
06972798250070069727982500706972798250070

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
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

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