Data / Medical devices / China / Ningbo Huiyoo Baby Products Co., Ltd.
Ningbo Huiyoo Baby Products Co., Ltd.: FDA-registered device maker in Cixi Zhejiang, China, 1 510(k) clearance
Ningbo Huiyoo Baby Products Co., Ltd. is registered with the FDA (registration 3014759586) in Cixi Zhejiang, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 16, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014759586
- Address
- 523# CiZhang Road, Zhangqi Industrial Area, Cixi Zhejiang, China, 315313
- Owner or operator
- NINGBO HUIYOO BABY PRODUCTS CO., LTD. (10061807)
- Roles
- Manufacturer
- First device listed
- November 20, 2019
- Registered through
- 2026
- Brand names listed
- BLA-8015,BLA-8015-02,BLA8015-02, BLA-8017-1,BLA-8017,BLA8017,BLA8012,BLA8013, BLA8019,BLA8020,BLA8021,BLA8022,BLA8023,BLA8024, BLA8034,BLA8035,BLA8037,BLA8038,BLA8039, BLA8040,BLA8041,BLA8042,BLA8043,BLA8040-2,BLA8042-2, RBX8015,RBX8020,RBX8021, RBX8029,RBX8030,RBX8028,RBX8031,RBX8037
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2020 | K191802 | Electric Breast Pump | HGX | Substantially Equivalent | Ningbo Huiyoo Baby Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 16, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.