Data / Medical devices / China / Huizhou LVB Maternal And Infant Supplies Co., Ltd.
Huizhou LVB Maternal And Infant Supplies Co., Ltd.: FDA-registered device maker in Huizhou Guangdong, China, 2 510(k) clearances
Huizhou LVB Maternal And Infant Supplies Co., Ltd. is registered with the FDA (registration 3029952735) in Huizhou Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029952735
- Address
- NO. 114,Xin Xing North Road, Sandong Town, Huicheng District, Huizhou City, Guangdong Province, P.R. China, Huizhou Guangdong, China, 516000
- Owner or operator
- HuiZhou LVB Maternal and Infant Supplies Co., Ltd. (10089060)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 2, 2023
- Registered through
- 2026
- Brand names listed
- 2-stage toddler toothbrush set/10592, 2-stage toddler toothbrush set/10593, 3-stage toothbrush set baby-to-toddler/10594, 3-stage toothbrush set baby-to-toddler/10595, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2), Wearable Breast Pump (ABP-1508), Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO,, Wearable Breast Pump (K6) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | 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 |
|---|---|---|---|---|---|---|
| September 11, 2024 | K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | HGX | Substantially Equivalent | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | accessdata.fda.gov |
| September 21, 2023 | K230102 | Smart double sides wearable breast pump, Electric bilateral breast pump | HGX | Substantially Equivalent | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2024. 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.