YOUHA

GUDID 16972798250152

The subject devices are wearable-style breast pumps designed for lactating women to express and collect milk from the breast. They are electrically powered, software controlled, digital pumps for a single user. The subject devices include The INs, The INs Gen 2, The INs NEXT, P1s, and P3 models, which are capable of expression,massage, and mixed modes with ten associated suction levels for each. All five models have a single pumping configuration and can be operated in ‘normal’ or ‘quiet’ modes.

Ningbo Youhe Mother And Baby Products Co., Ltd.

Breast pump, electric

• Primary Device ID: 16972798250152
• NIH Device Record Key: abeea052-6e4f-4143-8c41-9ab398312ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YOUHA
• Version Model Number: The INs NEXT
• Company DUNS: 412923842
• Company Name: Ningbo Youhe Mother And Baby Products Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972798250155 [Primary]
GS1	16972798250152 [Package]; Contains: 06972798250155; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242725

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07

On-Brand Devices [YOUHA]

• 06972798250018: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16972798250183: The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump pow
• 06972798250179: The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump pow
• 16972798250169: The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump pow
• 16972798250152: The subject devices are wearable-style breast pumps designed for lactating women to express and
• 16972798250145: The subject devices are wearable-style breast pumps designed for lactating women to express and
• 16972798250138: The subject devices are wearable-style breast pumps designed for lactating women to express and
• 16972798250084: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250077: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250060: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250053: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250046: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 06972798250032: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16972798250022: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact