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Electric Breast Pump BLA8019

by Ningbo Huiyoo Baby Products Co., Ltd.

Electric Breast Pump BLA8019 is a Class II device made by Ningbo Huiyoo Baby Products Co., Ltd., cleared under FDA 510(k) K191802 on 16 Jan 2020 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 06972562618044), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K191802

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06972562618044 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191802 Date16 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191802 decided 16 Jan 2020 Active
  • FDA GUDID UDI-DI 06972562618044 listed 27 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191802
  2. Listed FDA GUDID 06972562618044

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Electric Breast Pump
Generic name
Breast pump, electric
Model / reference
BLA8019
Primary DI / UDI-DI
06972562618044
510(k) Number
FDA product code
HGX
GMDN term
Breast pump, electric
Device class
Class II
Regulation number
884.5160
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

Other devices from Ningbo Huiyoo Baby Products Co., Ltd.

See all devices from Ningbo Huiyoo Baby Products Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)