FDA Registration
Active
🇨🇳 China
Guangdong Horigen Mother & Baby Products Co., Ltd.
Reg #: 3009700166
·
FEI: 3009700166
·
Expires 2026
Products
6
Proprietary Names
34
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- Registration Number
- 3009700166
- FEI Number
- 3009700166
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District
- City
- Shantou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K182413
Owner / Operator
- Firm Name
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- Operator Number
- 10046724
- Address
- No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District
- City
- Shantou
- State
- Guangdong
- Postal Code
- 515100
- Country
- CN
- Correspondent
- Changxin Chen
US Agent
- Business Name
- Osmunda Technology Co., Ltd.
- Contact Name
- Cancan Huang
- Address
- 949 White River Dr Allen, Allen, Texas
- City
- Allen
- State
- TX
- ZIP
- 75013
- Country
- US
- [email protected]
- Phone
- 858 3571157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2019-03-11 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-06-01 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2024-01-15 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-07-23 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-03-08 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2016-04-26 |
Proprietary Names
Electric Breast Pump
Portable Double electric breast pump(Model:XN-2223M2)
Electric Breast Pump (Model: SMG, GEA, SMG2, GEA2, GW)
Nanobebe Wearable Breast Pump (Model: FUS8510110);Nanobebe Wearable Breast Pump (Model: FUS8510210)
Electric breast pump (Model: XN/MD-2267A,XN/MD-2267B,XN/MS-2238A,XN/MS-2246A)
V6CO Pump-Y Electronic Double Breast Pump (Model: PY-1016A)
Electric breast pump(model:2259C)
Electric breast pump (Model: XN/MD-2249BS)
Biamba Pump Pro (Model:Bvk 20)
Double electric breast pump (Model: HD2721, XN/MS-2242A)
Electric breast pump(Model:D6)
Proture Double Electric Breast Pump(Model:XN-2208H2)
Biamba Pump Pro New (Model: Bvk 20up)
Electric breast pump(Model:Nurseva Pro-90A)
Electric breast pump(XN/MD-6602A)
Miture/ Niture Electric Breast Pump
Electric breast pump(XN/MS-6603A)
Single Electric Breast Pump(Item NO.:RTLBP1000);Double Electric Plus Breast Pump(Item NO.:RTLBP2000)
Electric breast pump (Model:XN/MD-2267R)
Hands-Free Double Electric Breast Pump(model:R1;R3;R5 Pro)
Electric breast pump (Model: ID2, HD2715, XN/MD-2267K)
Electric breast pump(XN/MD-6601A)
Electric breast pump (Model: MF1, F6, K3)
Single-use Medical Face Mask
Electric nasal irrigator(model:XB-F001)
Double Electric Plus Breast Pump(Item NO.:RTLBP0200)
Electric Breast Pump (Model No.: ZFHF)
2 in 1 lactation massager (model: B25650CQ),2 in 1 lactation massager (model: F8)
Biamba Massage-Cool (Model: Bv20)
Biamba Massage-Heat(Model: Bv19)
Single-use medical face mask
Manual Breast Pump
double electric breast pump
Electric breast pump(Model:MN-H1)
Establishment Types
Manufacture Medical Device