Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028606342

FEI Number

3028606342

Entity Name

OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 501 and Room 302,No.600-1,Guangshan 2nd Road,Fenghuang Streat,Tianhe Dist., Guangzhou Guangdong 510000, CN

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Foreign Private Label Distributor

Owner / Operator

Omay(Guangzhou) Med Technologies Co., Ltd (Owner Number: 10089276)

Owner / Operator Contact Address

Room 501 and Room 302,No.600-1,Guangshan 2nd Road,Fenghuang Streat,Tianhe Dist., Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191955

PMA Number

N/A

All Registered Proprietary Names

NovaHeart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRN	Device, Counter-Pulsating, External	Cardiovascular	Class 2	870.5225	2023-11-22

Official Correspondent

Jane Liao

US Agent Details

Paola Morales-Carvajal Business: NovaHeart Email: paola@novaheart.tech Phone: (787) 4243262

Related Public Records

Same Entity

Omay(Guangzhou) Med Technologies Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028606342. Last updated year: 2026. Please use registration number 3028606342 when referencing this establishment in official correspondence.