FDA Registration
Active
🇨🇳 China
Shenzhen Fortunecome Technology Co.,Ltd.
Reg #: 3011170521
·
FEI: 3011170521
·
Expires 2026
Products
7
Proprietary Names
94
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Shenzhen Fortunecome Technology Co.,Ltd.
- Registration Number
- 3011170521
- FEI Number
- 3011170521
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.57,SHANGXIA ROAD,BAOAN COMMUNITY,YUANSHAN STREET,LONGGANG DISTRICT
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Fortunecome Technology Co.,Ltd.
- Operator Number
- 10047995
- Address
- NO.57,SHANGXIA ROAD,BAOAN COMMUNITY,YUANSHAN STREET,LONGGANG DISTRICT
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518115
- Country
- CN
- Correspondent
- Annie Ye
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2014-11-23 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2021-01-25 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2015-01-28 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile | MCF | Class 1 | Dental | No | 2015-01-28 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | Class 1 | Dental | No | 2015-01-28 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-04-28 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2014-11-23 |
Proprietary Names
FL-V36; FL-V41; FL-V42; FL-V43;
FL-V5; FL-V5-X1; FL-V6; FL-V8; FL-V8-X1; FL-V8L; FL-V9;
FL-V16; FL-V17; FL-V18; FL-V19; FL-V20; FL-V22; FL-V23; FL-V24; FL-V26; FL-V27;
Unit, Oral Irrigation - D008;
N008; ORAL IRRIGATOR; V18plus; V8plus; WF-03; X01; X02; X03;
JYQ831; JYQ832; JYQ833; JYQ834; JYQ835; JYQ836; JYQ837; JYQ838; JYQ839; JYQ840; JYQ841; JYQ842; JYQ843; JYQ844; JYQ845
HL-B1; IP-1501; M008;
Model No.: FL-V2012;
Model No.: FL-V2101, FL-V2102, FL-V2103, FL-V2104, FL-V2105, FL-V2106, FL-V2107, FL-V2108, FL-V2109, FL-V2110, FL-V2111;
Oral Plaque & Tartar Remover Kit: FL-V34; FL-V38; FL-V39; FL-V40; C11; C22; C33; C44; C66; C77; C88; C99
FL-V28; FL-V29; FL-V30; FL-V31; FL-V32; FL-V33; FL-V35;
YASI 911; YASI 912; YASI 913; YASI 915; YASI 916; YASI 917;
Model No.:FL-V21-X1, FL-V22-X1, FL-V23-X1, FL-V25-X1, FL-V26-X1, FL-V28-X1, FL-V29-X1, FL-V30-X1, FL-V31-X1
Model No.: FL-V32-X1, FL-V33-X1, FL-V35-X1, FL-V36-X1
Model No.: YY-C02, YY-C03, YY-C04, YY-C05, YY-C06, FL-V5-X1, FL-V8-X1, FL-V8L-X1, FL-V17-X1, FLV-18-X1, FL-V19-X1, FL-V20-X1
X1, X2, X3, X5, X6, X7, X8, X9
FL-A14
ELECTRONIC TOOTHBRUSH
FL-A18
FL-A15
YASI 702
YASI 517
FL-A11
FL-A17
FL-A19
YASI 511
YS964
YS973
FL-A16
FL-A150
FL-A13
YASI 518
YASI 705
FL-A9
FL-A12
FL-A10
YASI 708
YS971
FL-A8
YS969
YS961
FL-A400
YS970
FL-A350
FL-A20
FL-A550
YS967
FL-A21
FL-A300
FL-A200
FL-A450
YS975
YS976
FL-A26
FL-A24
YS972
H002
YS974
FL-A600
FL-A100
FL-A27
YS968
YS963
FL-A22
FL-A500
YS965
FL-A23
H008
ST02
H007
ST01
FL-A28
FL-A30
H003
ST03
YS962
H009
FL-A23M
ET01
FL-A29
FL-K05
FL-A22M
FL-A29M
FL-A28M
FL-K01
FL-K03
FL-K02
FL-A30M
FL-A27M
FL-A25M
FL-A26M
FL-K06
FL-A24M
Model No.: FL-A2108, FL-A2109, FL-A2110, FL-A2111, FL- A2012
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device