FDA.report

eufy Wearable Breast Pump S1 Pro

Primary DI
04897152760045
Brand
eufy Wearable Breast Pump S1 Pro
Company
Anker Innovations Limited
Model
T8D04
Device description
eufy Wearable Breast Pump S1 Pro (T8D04)
Published
2026-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HGXPump, Breast, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K250152000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250152000eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;Shenzhen TPH Technology Co., Ltd.2025-04-02HGX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04897152760045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04897152760045048971527600454897152760045

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
663903915
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04897152760038eufy Wearable Breast Pump S1T8D022026-03-13
04897152760052eufy Wearable Breast Pump E10T8D032026-03-14
04897152760069eufy Wearable Breast Pump E20T60602026-03-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04897152760052eufy Wearable Breast Pump E10Anker Innovations LimitedHGX2026-03-14
04897152760069eufy Wearable Breast Pump E20Anker Innovations LimitedHGX2026-03-14
04897152760038eufy Wearable Breast Pump S1Anker Innovations LimitedHGX2026-03-13
39551028430000AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054982Ardo MeliaArdo medical AGHGX2026-02-27
28809108019916SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
26973493597341TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
26973493599437TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493598419AmedaShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592223MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592438lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592537MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493593992MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594241MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594371MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597075MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597990MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598232MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598348MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
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28809108019770SpectraUZINMEDICARE CO.,LTDHGX2026-02-03