Guangdong Horigen Mother & Baby Products Co., Ltd.
Shantou Guangdong, CN
Guangdong Horigen Mother & Baby Products Co., Ltd. appears in FDA device records in Shantou Guangdong, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Guangdong Horigen Mother & Baby Products Co., Ltd. between 2016 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212564 | Electric Breast Pump | HGX | Substantially Equivalent | |
| K201152 | Electric Breast Pump | HGX | Substantially Equivalent | |
| K201974 | Single-use medical face mask | FXX | Substantially Equivalent | |
| K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | HGX | Substantially Equivalent | |
| K182413 | Electric Breast Pump | HGX | Substantially Equivalent | |
| K162747 | Proture Double Electric Breast Pump | HGX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009700166 | 3009700166 | Guangdong Horigen Mother & Baby Products Co., Ltd. | No. 18, Pingnan Industrial Zone, Mianbei Street, Shantou Guangdong 515100 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain