Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030536467

FEI Number

3030536467

Entity Name

GUANGDONG ERACLEAN TECHNOLOGY CO.,LTD

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

3rd Floor, 1st Block, Phase 4, Hongji Industry City, No.23 Tongji West Road, Nantou Town, Zhongshan City Guangdong 528427, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong EraClean Technology Co.,Ltd (Owner Number: 10089844)

Owner / Operator Contact Address

3rd Floor, 1st Block, Phase 4, Hongji Industry City, No.23 Tongji West Road, Nantou Town, Zhongshan City, CN-GD 528427, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EraClean,Portable oral irrigator,WF-T01,WF-T02,WF-T03,WF-T04,WF-T05,WF-T06,WF-T07,WF-T08 GT17,GT18,GT19,GT20;GC01,GC02,GC03,GC04,GC05 ,GC06,GC07 GC08,GC09,GC10,GC11,GC12,GC13,GC14,GC15,GC16,GC17,GC18 GM11,GM12,GM13,GM14,GM15;GMN1,GMN2,GMN3,GMN4,GMN5,GMN6,GMN7,GMN8 Sonic Spa Pro; Sonic Odyssey;Sonic Pro GW01,GW02,GW03,GW04,GW05,GW06,GW07,GW08;DC01,DC02,DC03 GSB04,GSB05 GTM8,GM01,GM02,GM03,GM04,GM05,GM06,GM07,GM08,GM09,GM10 GFC15,GFC16,GFC17,GFC18 Cleaner, Ultrasonic, Medical Instrument - EraClean,UltrasonicCleaner, GA01,GA02,GA03,GA04,GA05,GA06,GA07,GA08,GE01,GE02 DCS03,DCS04,DCS05,DCS06,DCS07,DCS08,DCS09,DCS10,DCS11 Fruit & Vegetable Cleaner GFC01,GFC02,GFC03,GFC04,GFC05,GFC06,GFC07,GFC08;GFC09,GFC10 DC09,DC10,DC11,DC12,DC13,DC14,DC15,DC16,DC17,DC18,DC19;DCS01,DCS02 GT04,GT05,GT06,GT07,GT08,GT09,GT10,GT11,GT12,GT13,GT14,GT15,GT16 GE03,GE04,GE05,GE06,GE07,GE08,GTM1,GTM2,GTM3,GTM4,GTM5,GTM6,GTM7 DCS12,DCS13,DCS14,DCS15;UCB01,UCB02,UCB03,UCB04,UCB05,UCB06,UCB07,UCB08 Orthokeratology Lenses (Ortho-K) Cleaner,GOK1,GOK2,GOK3, GOK4,GOK5,GOK6,GOK7,GOK8 DC04,DC05,DC06,DC07,DC08 GL01,GL02,GL03,GL04,GL05,GL06,GL07,GL08;GT01,GT02,GT03 GFC11,GFC12,GFC13,GFC14,GFC15

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-01-12
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2024-01-12

Official Correspondent

Jiezong He

US Agent Details

Lucika He Email: lucikahe1999@gmail.com Phone: (702) 2681984

Related Public Records

Same Entity

Guangdong EraClean Technology 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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3006572778	IN'TECH INDUSTRIES	Ramsey, MN, US
3005607635	HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO.,	XIAMEN Fujian, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030536467. Last updated year: 2026. Please use registration number 3030536467 when referencing this establishment in official correspondence.