Fudakang Industrial Co Ltd
Manufacturer and brand owner in Dongguan, Guangdong, China. 3 device types, 6 products catalogued, 4 clearances.
Fudakang Industrial Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Clinical Electronic Thermometer, Continuous Measurement Thermometer and 1 other device type. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | FUDAKANG INDUSTRIAL CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008167616 |
| FEI number | 3008167616 |
| DUNS | 118811334 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 东莞市福达康实业有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 501, Building 2, No. 11 Changheng Road, |
| Postal code | 523560 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Premom Smart Basal Thermometer: EBT-380, Clinical Electronic Thermometer FDK: BT-A11CN, BT-A41CN, Easy@Home Smart Basal Thermometer: EBT-300, Easy@Home Digital Basal Thermometer: EBT-100, EMT-A12 | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | Reizen Digital Thermometer: BT-A31, FDK Digital Thermometer: BT-A21CN, BT-A31CN, BT-A12, BT-A13, BT-A51, Banner Health Digital Thermometer: BHTRA01 (BT-A11CN), FDK Thermomter with bluetooth without display: BT-A31A-BT, Prex: BT-A31-BT, FDK Digital Thermometer with bluetooth: BT-A41CN-BT and 4 more | 2010 | 115 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | FDK ARM Cuff BPM W/NO Voice: FT-C22Y, Blue Jay Arm & Wrist BPM:FT-C06(BJ120108), FDK ARM Cuff BPM W/Voice: FT-C23Y-V, FDK Wrist Cuff BPM: FT-B31Y, Sunbeam Wrist BPM : FT-B06W-V, FDK ARM Cuff Blood Pressure Monitor: FT-C15B and 4 more | 2015 | 98 |
Own-Brand Listings
Clearances
4 clearances name Fudakang Industrial Co Ltd as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K172121 | 2018-06-07 | FLL | Traditional | This company |
| K160308 | 2016-07-15 | FLL | Special | This company |
| K150430 | 2015-04-17 | DXN | Traditional | This company |
| K111703 | 2012-03-29 | FLL | Traditional | This company |
| K152640 | 2016-03-28 | FLL | Special | Fudakang Industries Co., Ltd. |
| K101387 | 2010-08-03 | FLL | Traditional | Fudakang Industries Co., Ltd. |
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.