OMEDIC TECHNOLOGY (DONGGUAN) CO., LTD

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3022553912

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022553912
FEI Number
3022553912
Entity Name
OMEDIC TECHNOLOGY (DONGGUAN) CO., LTD
City/State/Country
Dongguan Guangdong, CN
Establishment Address
Room 302, Building 1, No.8, Shizhai Road, Chang'an Town, Dongguan Guangdong 523850, 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
Owner / Operator
Omedic Technology (Dongguan) Co., Ltd (Owner Number: 10084669)
Owner / Operator Contact Address
Room 302, Building 1, No.8, Shizhai Road, Chang'an Town, Dongguan, CN-GD 523850, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

shockwave SHOCK VITALIZE EVO,SHOCK VITALIZE CURA,SHOCK VITALIZE NEO ONE,SHOCK VITALIZE CORE,SHOCK VITALIZE PRIME OMS01.OMS02,OMS03,OMS05,OMS06,OMS07,OMS08, ShockVitalize Mega,ShockVitalize Plus,ShockVitalize Cube,SHOCK VITALIZE LITE,SHOCK VITALIZE FOCUS,SHOCK VITALIZE OPTIMA SHOCK VITALIZE AXIS,SHOCK VITALIZE NOVA Ultrasonic tooth cleaner,Ultrasonic Calculus Remover,Dental Plaque Tool Teeth Cleaning Kit CH066,CH068,CH065,CH063,CH069,OMU01,OMU02,OMU03,OMU05,OMU06 Electric toothbrush , sonic toothbrush , toothbrush , dentalbrush , oral brush ,teethbrush Electric toothbrush, sonic toothbrush, toothbrush, dentalbrsh, oral brush, teethbrush OMT01,OMT02,OMT03,OMTO4, OMT05,OMT06,OMT08,OMT09,OMT10,VI,V2 S2009 OMT11,OMT12,OMT13,MC3105,MC3106,MC3107,MC3108,MC3109,MC3110,MC3101,MC3102,MC3103 Red Light Eye Mask OMI01,OMI02,OMI03,OMI04,OMI05,OMI06,OMI07,OMI08,OMI09,OMI10 Body Red Light Therapy Infrared Lamp Panel OMP07,OMP08,OMP09,OMP10,OMPA1,OMPA2,OMPA3,OMPA4,OMPA5,OMPA6,OMPA7,OMPA8, Infrared Light Therapy Device Red Light Therapy Device PotonBeam Pro,PotonBeam Basic,PotonBeam Elite,OMH01,OMH02,OMH03,OMH04, OMH05 ,OMH06 OMP01,OMP02,OMP03,OMP04,OMP05,OMP06. Elite 60 Elite 156 Elite 315 Elite 610 Elite 928 M01,M02,M04,M05,M06,M07,M08,M09,M10 Core 60 Core 156 Core 315 Core 610 Core 928 Infrared Light Therapy DeviceRed Light Therapy Device OMH07,OMH08,OMH09,OMH10 Infrared Lamp Panel Body Red Light Therapy OMPB2,OMPB3,OMPB4,OMPB5,OMPB6,OMPB7,OMPB8,OMPB9,OMPC1,OMPC2,OMPC3,OMPC4,OMPC5,OMPC6,OMPC7,OMPC8,OMPC9,PRO60 Body Contouring Device OBC01,OBC02,OBC03,OBC04,OBC05,OBC06,OBC07,OBC08,OBC09,OBC10 NeoMat M1 ,M2 ,M3 ,M4 ,M5 ,OMY01 ,OMY02 ,OMY03 ,OMY04 ,OMY05 Infrared Lamp Panel Basic 60 ,Basic 156 ,Basic 315 ,Basic 610 ,Basic 928 Elite 78,Elite 150,Elite 300,Pro 78,Pro 150,Pro 300,Basic 78,Basic 150,Basic 300,Core 78,Core 150,Core 300, Pro 60 Pro 156 Pro 315 Pro 610 Pro 928 Red Light Therapy Yoga Mat OMY01,OMY02,OMY03,OMY04,OMY05,OMY06,OMY07,OMY08,OMY09,OMY10 Nasal irrigator, irrigator nasal, nose irrigator, nose water jet OMN01,OMN02,OMN03,OMNO4, OMN05,OMN06,OMN08,OMN09,OMN10 Oral irrigator ,dental oral irrigator ,irrigator oral , dental water jet ,water flosser , dental water flosser , OMT06,OMT07,OMT08 ,OMT09,OMT10, OMT01,OMT02,OMT03,OMT05. water flosser pick ,cordless oral irrigator ,portable dental oral irrigator , dental jet , water dental pick , MC3108,MC3109 MC3107,MC3110,S2009 dental irrigator Oral irrigator ,dental oral irrigator ,irrigator oral , dental water jet ,water flosser , dental water flosser, OMD01,OMD02,OMD03,OMD05,OMD06,OMD07,OMD08,OMD09,OMD10,OMD11,OMD12,OMD13,OMD15,OMD16,OMD17,OMD18 water flosser pick,cordless oral irrigator,portable dental oral irrigator,dental jet,water dental pick,dental irrigator XY02 OME01,OME02,OME03,OMEO4, OME05,OME06,OME08,OME09,OME10,Z10,AN108 Y1,Y2, Y3, Y5 , Y6 ,Y7,Y8 electric ear washing device ,ear cleaner device Electric ear wax remover ,Electric ear cleaner , Electric ear clean kit , Ear irrigation device ,water ear pick , Photon LED Light Therapy Face Mask Quint,Quad,RNI,OMF01,OMF02,OMF03 ,OMF04,OMF05,OMF06 silicone facial led face mask

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2024-12-25
QJC Plaque Disclosing Agent Dental Class 1 872.6855 2024-12-25
JEQ Toothbrush, Powered Dental Class 1 872.6865 2022-03-20
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2023-12-20
KMA Irrigator, Powered Nasal Ear, Nose, Throat Class 1 874.5550 2022-03-20
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2022-03-20
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2022-03-20
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2023-12-19

Official Correspondent

xiaoli Tan

US Agent Details

jimmy chen Business: UGK-LVM UNITED INC Email: 1841621950@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

Omedic Technology (Dongguan) Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022553912. Last updated year: 2026. Please use registration number 3022553912 when referencing this establishment in official correspondence.
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