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Unimom Opera

by Unimom.Co

Unimom Opera is a Class II device made by Unimom.Co, cleared under FDA 510(k) K190810 on 30 Aug 2019 and listed in FDA GUDID since 4 Oct 2019 (UDI-DI 08809224872262), active as of 23 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 23 Oct 2026

Documents

510(k) K190810

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809224872262 UDI-DI Date4 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190810 Date30 Aug 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190810 decided 30 Aug 2019 Active
  • FDA GUDID UDI-DI 08809224872262 listed 4 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190810
  2. Listed FDA GUDID 08809224872262

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Unimom
Generic name
Breast pump, electric
Model / reference
Opera
Primary DI / UDI-DI
08809224872262
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

Related devices

Category: Breast pump, electric

Cleared under the same submission (K190810)

Similar devices

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

Other devices from Unimom.Co

See all devices from Unimom.Co →

Properties

  • Over-the-counter
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)