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Omay OM-A-II

by Omay(Guangzhou)Med Technologies Co., Ltd.

Omay OM-A-II is a Class II device made by Omay(Guangzhou)Med Technologies Co., Ltd., listed in FDA GUDID since 24 Sep 2026 (UDI-DI 06975435800096), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975435800096 UDI-DI Date24 Sep 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Omay
Generic name
External counterpulsation system, stationary
Model / reference
OM-A-II
Primary DI / UDI-DI
06975435800096
FDA product code
DRN
GMDN term
External counterpulsation system, stationary
Device class
Class II
Regulation number
870.5225
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code DRN (Device, Counter-Pulsating, External).

Other devices from Omay(Guangzhou)Med Technologies Co., Ltd.

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)