FDA Registration
Active
🇨🇳 China
CHANGSHA GOMECY ELECTRONICS CO., LTD.
Reg #: 3043654467
·
FEI: 3043654467
·
Expires 2026
Products
9
Proprietary Names
24
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- CHANGSHA GOMECY ELECTRONICS CO., LTD.
- Registration Number
- 3043654467
- FEI Number
- 3043654467
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 2501, Building 11, Dangdai Binjiangyuan, No. 125 Hanguang Road, Guanshalin Street, Yuelu District,
- City
- Changsha Hunan
- Country
- CN
Owner / Operator
- Firm Name
- Changsha GOMECY Electronics Co., Ltd.
- Operator Number
- 10094986
- Address
- Room 2501, Building 11, Dangdai Binjiangyuan, No. 125 Hanguang Road, Guanshalin Street, Yuelu District,
- City
- Changsha
- State
- Hunan
- Postal Code
- 410000
- Country
- CN
- Correspondent
- Meiling Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2026-01-12 |
| Gas, Laser Generating | NXF | Class 1 | General, Plastic Surgery | No | 2026-01-12 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2026-01-12 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2026-01-12 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-01-12 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2026-01-12 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2026-01-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2026-01-12 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-01-20 |
Proprietary Names
Plasma Machine:GMS PM 01, GMS PM 02, GMS PM 03, GMS PM 04, GMS PM 05. GMS A59, GMS B59
Cryolipolysis Slimming Machine:GMS 360 Cryo P03, GMS 360 Cryo P04
Laser Multifunctional Machine:GMS-M01, GMS-M02, GMS-M03, GMS-M04, GMS-M05
Hair Removal Machine:Glory, Faery, K8, K9, K10, K11, K16, K17, K18, 808-A, 808-B,808-C,808-D,808-E,808-H, 808-M
Pico Laser Tattoo Removal :Picory, PicoNova, GMS260, GMS280, GMS580, GMS-Q5, GMS-Q6, GMS-Q7, GMS-Q8
Q-switched Nd:Yag Laser Machine:GMS-Q1, GMS-Q2, GMS-Q3, GMS-Q4, GMS-Q5, GMS-Q6, GMS-Q7
Co2 Fractional Laser:GMS-C1, GMS-C2, GMS-C3, GMS-C4, GMS-C5, GMS-C6
PMS PMST 3 Neo, PMST 4 Neo, PMST 1Neo+, PMST2Neo+, PMST 3NeO+, PMST 4Neo+, PMSTWAVE, PMST WAVE NEO+, PMST 687, PMST 682,
GMS IP 50,GMS IP 1064, GMS IP 20, PSW 01, PSW02, ESW01, ESW 03, EMSW 01, EM-F, ULSW01, ESWT Double C,
Physiotherapy Machine:PMST2, PMST3, PMST4, PMST1NeO, PMST2Neo, Panacea01, Panacea 02, Panacea 650,10D Luxmaster,
PMST MAX, PMST DUO MAX, PMST LOOP, PMST LOOP PRO, PMST LOOP PRO MAX, PMST+6D, ESWT-GMS-B Pro,
ESWT Double B,Tecar O1,Tecar Tecar 03,Tecar ProTecar Pro+Tecar BAT 3S+, A63, B63, A69, SW7
Hydra Dermabrasion Machine:H5020, H5021, SPA01, SPA02, WA16, W05X 3 & 4
IPL SHR Machine:Faery, GMS-P1, GMS-P2, GMS-P3, GMS-P4, GMS-P5
Emslim Machine:139A,1139B,1139C,1139D,1139E,1139F,1139G,1139H,1139I,1139J,
1139K,1139L,1139M,1139N,1139A+RF,1139B+RF,1139C+RF, 1139D+RF,1139E+RF,1139F+RF,1139G+RF,1139H+RF,
11391+RF, 1139J+RF, 1139L+RF
Lipo Laser Slimming Machine:6D P01, 6D P02, 6D V01
Micro-needles RF Machine:GMS-H1, GMS-H2, GMS-H3, GMS-H4, GMS-H5, GMS-H6, GMS-H7, GMS-A2, GMS-A27 GMS-M8
VelaShape Slimming Machine:GMS-VE8, GMS-VE9, GMS-VE10, GMS-VE10 Pro, GMS-VE11,
GMS-VEP8, GMS-VEP9, GMS-V9, GMS-V10, GMS 360 Cryo P01, GMS 360 Cryo P02
Nail Drill Machine:M0108, M0130, M0101
980-A,980-B,980-C,980-D,980-E,980-F,1470-A,1470-B,1470-C
Diode laser therapy device:Panacea, PrismaLift, Pegasus, GMS-01, GMS-02, GMS-03, GMS-04,
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)