FDA Registration
Active
🇨🇳 China
dr.Madre: BT-A41CN (DRM-BT41)
Reg #: 3008167616
·
FEI: 3008167616
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FUDAKANG INDUSTRIAL CO LTD
- Registration Number
- 3008167616
- FEI Number
- 3008167616
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 301,3F,NO.60 BLOCK 1,SHANGSHUXIA RD,, CHANGPING TOWN,
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K101387
Owner / Operator
- Firm Name
- Fudakang Industrial Co Ltd
- Operator Number
- 10031413
- Address
- 301,3F, BLOCK 1,NO.60,SHANGSHUXIA ROAD,, CHANGPING TOWN,
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523560
- Country
- CN
- Correspondent
- Bob Yu
US Agent
- Business Name
- Fudakang Industrial Inc.
- Contact Name
- Jephanie Chen
- Address
- 3514 Raina Ridge Ct
- City
- Las Vegas
- State
- NV
- ZIP
- 89121
- Country
- US
- [email protected]
- Phone
- 725 7266008
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2010-08-16 |
Proprietary Names
dr.Madre: BT-A41CN (DRM-BT41)
LPOW: BT-A13
SPLENDCARE: BT-A12B(SPT-01)
ADVOCATE Large Display Backlit Digital Thermometer: BT-A31(ADPT-01)
ChoiceMMed: BT-A11CN(T100)
Pro Temp: BT-A21CN
Safety: TH093, TH094
FDK DIGITAL THERMOMETER : BT-A11CN, BT-A21CN, BT-A31CN, BT-A41CN, BT-A13
easy@Home: EBT-100(BT-A23), EMT-A12(BT-A12B), EMT-021(BT-A21CN)
Ckeep: BT-A11CN, BT-A13
ANKOVO: BT-A21CN
shecare:BT-A12A
Sunbeam: BT-A22
Uone: UO-8064
BENDI-C: BT-A21B, BT-A21C, BT-A21D, BT-A21E, BT-A21F, BT-A21G, BT-A21H, BT-A21I, BT-A21J
Babyplan: BT-A31CN
REIZEN: BT-A31
Establishment Types
Manufacture Medical Device