Zhongshan Xiaolan Town Senlan Electronic Factory
Registered establishment in Zhongshan, Guangdong, China. 4 device types, 1 clearance.
Zhongshan Xiaolan Town Senlan Electronic Factory is a manufacturer holding a current FDA establishment registration. The registration covers Monitor, Ultrasonic, Fetal, Hearing Aid, Air-Conduction, Prescription and 2 other device types. Its earliest product listing with the FDA dates from 2021.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016587556 |
| FEI number | 3016587556 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 中山市小榄镇森蓝电子厂 |
|---|---|
| Unified social credit code | 91442000L024028666 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | 2/F, Plant 3, No.39 of Jucheng Avenue East, Xinshi Community, Xiaolan Town |
| Postal code | 528415 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Hearing Aid with Wireless Technology, A2-D2/A6-G/A3-G1T/A6-G2/K-81/K-812/K-87 | 2022 | 52 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Hearing Aid, A-90; G5; G6, F-139/F-136/V-163/F-137/B-13/V-168/F-138/X-168/V-185/V-183/V-188B/V-263PB/F-998B/E-103/B-18/B-19/K-80/K-82/K-86/K-188/K-88/X-136, F-18/F-28/V-68/F-16/V-99/A-155/C-108/C-109/A-80/A-60/E-9/D-322/D-303/A-111/B-63/F-22/A-360/A-318/K-89/F-135B/A-208/V-168B/V-189B/A-130, A-209D | 2022 | 57 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | HA201/K-98/HAT605/HAT606/HAT607/HAT608/A-381/A-382/A-383/A-383/A-360/A-130/A-318/A-133/F-998/V-188/K-89/A-208B, A1-D1, A1-D2, A2-DA, A2-D2, A2-D3, A3-G1T, A3-G2T, A6-G1T, A6-G2T, A6-G3T, A6-G, A-130B;A-208B;F-135B;F-136B;F-138TB;F-139B;F-998B;V-168B;K-100;K-108;K-200;K-208;K-300;K-303;F-16;F-28;V-68;V-99, Hearing Aids | 2021 | 45 |
| Monitor, Ultrasonic, Fetal | Class 2 | Fetal Doppler, U8-25, U9-25 | 2026 | 13 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252669 | 2026-01-08 | KNG | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.