Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017618900

FEI Number

3017618900

Entity Name

HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD

City/State/Country

huizhou Guangdong, CN

Establishment Address

LEFT 2ND FLOOR, NO.3 LEJIN NORTH ROAD, NO.24 DISTRICT, ZHONGKAI DEVELOPMENT ZONE, huizhou Guangdong 516000, CN

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Huizhou Gold Rose Technology Co.,Ltd (Owner Number: 10078391)

Owner / Operator Contact Address

LEFT 2ND FLOOR, NO.3 LEJIN NORTH ROAD, NO.24 DISTRICT, ZHONGKAI DEVELOPMENT ZONE, HUIZHOU, CN-GD 516000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing Aid Z3-Pro,HD100,E6,RSH05,RSH20 OTC hearing aids G-116,G-208,G-216,G-216TE,G-316,G-516,Z3Free,W3,Q4,S450,H51 G102D,G600D,G600S,G900,G900D,S360,G12X,G16,G17,G17D,G19,G-108 ZR-H702,S450,S350,ZR-H706,S350D,S650,S700,ZR-H711A,ZR-M902,G300L G300,G400L,G400S,G400H,G400D-H,G400D-S,G500,G430,G330,G102 electric toothbrush BA-8008 Z1T Z7T EMS Face Lifting Device breast massager V10 S19 S18 Green Light Therapy Lamp S18 PRO S19 PRO SAD Light Red Light Therapy S18G UV sterilizer Menstrual cup sterilizer Ozone sterilizer CPAP Cleaner Steam sterilizer Q8 HD100 MCS2E DC100 S4 DC200 MCS2 S4Plus Q5 S500 S4A S600 S3 DC300 HD100L nasal aspirator Nasal Irrigator Brace US600 US500 US900 US800 Ultrasonic Cleaner US400 US200 US100 US4 US700 US300 US202 US201 WF200 WF100 WF300 water flosser Teeth Whitening Kit dental floss electric Z2,Z8,Z9,Z10,Z11,Z12,Z13,Z14 Z3,Z1,Z4,Z5,Z6,Z7,Z15 The Electric Dental Flosser breast pump earwax removel M11 Oral Red Light Massager G-216TE, G-316, G-516, Z3 Free, W3, Q4, S450, H51, Z3-Pro HD100, E6, RSH05, RSH20 RSH052 ZR-H702, S450, S350, ZR-H706, S350D, S650, S700, ZR-H711A, ZR-M902, G300L, G300, G400L, G400S, G400H, G400D-H, G400D-S RSH05BG RSH05GY RSH05BK RSH052BG RSH052GY RSH052BK RSH20WH RSH20BGW RSH20GYW G500, G430, G330, G102, G102D, G600D, G600S, G900, G900D, S360, G12X, G16, G17, G17D, G19, G-108, G-116, G-208, G-216 Y32PRO Y32 Y40 Y27 Y50 Y25 Y10PRO Y33 Y10 earplugs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2020-12-01
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-12-28
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-11-22
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-11-10
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-10-20
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2026-06-08
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2022-12-21
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2021-11-10
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2023-12-23
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2021-11-10
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2025-12-28
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2021-11-10
JES	Floss, Dental	Dental	Class 1	872.6390	2024-04-23
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2022-12-21
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2022-12-21
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2025-12-28
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2023-02-17
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2025-12-29

Official Correspondent

zhongjian zhou

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Huizhou Gold Rose 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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

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3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
1056339	EAR TECHNOLOGY CORPORATION	Johnson City, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017618900. Last updated year: 2026. Please use registration number 3017618900 when referencing this establishment in official correspondence.