FDA Registration
Active
🇨🇳 China
HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD
Reg #: 3017618900
·
FEI: 3017618900
·
Expires 2026
Products
19
Proprietary Names
96
Establishment Types
7
Classifications
19
Registration Details
- Registration Name
- HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD
- Registration Number
- 3017618900
- FEI Number
- 3017618900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LEFT 2ND FLOOR, NO.3 LEJIN NORTH ROAD, NO.24 DISTRICT, ZHONGKAI DEVELOPMENT ZONE
- City
- huizhou Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Huizhou Gold Rose Technology Co.,Ltd
- Operator Number
- 10078391
- Address
- LEFT 2ND FLOOR, NO.3 LEJIN NORTH ROAD, NO.24 DISTRICT, ZHONGKAI DEVELOPMENT ZONE
- City
- HUIZHOU
- State
- Guangdong
- Postal Code
- 516000
- Country
- CN
- Correspondent
- zhongjian zhou
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2020-12-01 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2025-12-28 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2023-11-22 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-11-10 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-10-20 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2026-06-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2022-12-21 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2021-11-10 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2023-12-23 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2021-11-10 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2025-12-28 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2021-11-10 |
| Floss, Dental | JES | Class 1 | Dental | No | 2024-04-23 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2022-12-21 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2022-12-21 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2025-12-28 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2023-02-17 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2025-12-29 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2024-05-08 |
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
TC500
TC05
TC100
TC02
TC300
TC400
TC03
TC200
TC04
TC01
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198