FDA Registration
Active
🇨🇳 China
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
Reg #: 3021376102
·
FEI: 3021376102
·
Expires 2026
Products
7
Proprietary Names
24
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
- Registration Number
- 3021376102
- FEI Number
- 3021376102
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict, Nanshan District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K251394
Owner / Operator
- Firm Name
- Shenzhen Root Innovation Technology Co., Ltd.
- Operator Number
- 10083690
- Address
- Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict,, Nanshan District, Shenzhen, Guangdong, China, 518071
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518071
- Country
- CN
- Correspondent
- Athena Pan
US Agent
- Business Name
- ROOT TECHNOLOGY LTD.
- Contact Name
- Amy Dong
- Address
- 1580 N Logan St Ste 660 #30327
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 424 5137016
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2025-09-16 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2025-08-05 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2024-11-29 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2026-03-16 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2026-05-27 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2026-01-12 |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | Class 1 | Obstetrics/Gynecology | No | 2024-12-26 |
Proprietary Names
Momcozy Wearable Breast Pump (BP223)
Momcozy Wearable Breast Pump (S9 Pro, S12 Pro)
Momcozy Wearable Breast Pump (S9 Pro & S12 Pro );
Momcozy Wearable Breast Pump (BP380)
Momcozy Wearable Breast Pump (Model BP334)
Momcozy Wearable Breast Pump (Model BP380)
Momcozy Wearable Breast Pump (Model BP420)
Momcozy Wearable Breast Pump kit(Flange, Valve, Milk Collector, Flange Insert, Flange Cover)
Momcozy Maternity Belt (Model: YB001,YB002); Momcozy Recovery Belly Belt (Model: RB001)
Momcozy Maternity Belt (Model: YB003)
MeggO Maternity Ball (Model: MeggO)
Momcozy Wearable Breast Pump (Model S10); Momcozy Wearable Breast Pump (Model X1);
Baby Nasal Aspirator (Model BN008)
Baby Nasal Aspirator (Model BN006)
Momcozy Wearable Breast Pump BP137; Momcozy Wearable Breast Pump BP141
Momcozy Nasal Aspirator (Model BN007)
Momcozy Wearable Breast Pump(M5); Momcozy Wearable Breast Pump(M5-N)
Momcozy Wearable Breast Pump (BP334)
BambooFlex 3-in-1 Compression Socks (Model: SO016)
MoveWell Sports Compression Socks (Model: SO034)
MediStep Compression Socks (Model: SO033)
Momcozy Wearable Breast Pump (BP311)
Momcozy Wearable Breast Pump (BP137, BP141)
Momcozy Wearable Breast Pump Accessories(Flange, Flange Cover, Milk Collector, Flange Insert)
Establishment Types
Manufacture Medical Device