Youha Powered breast pump

FDA UDI

Class II (US FDA UDI)

by Ningbo Youhe Electrical Appliance Technology Co., Ltd.

Identity

Trade Name: Youha Powered breast pump FDA UDI
Generic Name: Breast pump, electric FDA UDI
Device Name: 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. FDA UDI
Model / Reference: YH- 8012 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 06957031400078 FDA UDI
510(k) Number: K203148 FDA UDI
FDA Product Code: HGX FDA UDI
GMDN Term: Breast pump, electric FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Breast pump, electric

Youha Powered breast pump by Ningbo Youhe Electrical Appliance Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K203148 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ningbo Youhe Electrical Appliance Technology Co., Ltd.

Sources (1)

FDA UDI bffe6c3c-0f0a-421f-8ab6-aa8c29ee0910 34 fields · synced Jun 8, 2026