FDA Registration
Active
🇨🇳 China
FAMIDOC TECHNOLOGY CO., LTD
Reg #: 3005621440
·
FEI: 3005621440
·
Expires 2026
Products
9
Proprietary Names
53
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- FAMIDOC TECHNOLOGY CO., LTD
- Registration Number
- 3005621440
- FEI Number
- 3005621440
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 6, Zhongtangtian'An Cyber Park, No. 89, Jinyuan Road, Zhongtang Town
- City
- Dong Guan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222887
Owner / Operator
- Firm Name
- FAMIDOC TECHNOLOGY CO., LTD.
- Operator Number
- 9078379
- Address
- Building 6, Zhongtang Tian'an Cyber Park, No. 89, Jinyuan Road, Zhongtang Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523220
- Country
- CN
- Correspondent
- Liang - Cao
US Agent
- Business Name
- Clinical Guard
- Contact Name
- Yue Zhang
- Address
- 2625 Piedmont Rd Ne Ste 56-129 Atlanta Ga 30324
- City
- Atlanta
- State
- GA
- ZIP
- 30324
- Country
- US
- [email protected]
- Phone
- 678 9994508
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-05-11 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2014-02-12 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2014-02-12 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2022-08-18 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-07-14 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-14 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2013-01-04 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2013-01-04 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-01 |
Proprietary Names
Upper Arm Blood Pressure Monitor( Model:BUA4000BUS,BUA4075BUS)
Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A1B,FDBP-A2B,FDBP-A3B,FDBP-A4B,FDBP-A5B,FDBP-A6B)
Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A9,FDBP-A9B,FDBP-A9BL,FDBP-A9BT,FDBP-A9BLT)
Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A10,FDBP-A10B,FDBP-A10BL,FDBP-A10BT,FDBP-A10BLT)
Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A7,FDBP-A7B,FDBP-A7BL,FDBP-A7BT,FDBP-A7BLT)
LOOKEE® UPPER ARM BLOOD PRESSURE MONITOR(Model No.:FDBP-A2,LK-A2)
Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A8,FDBP-A8B,FDBP-A8BL,FDBP-A8BT,FDBP-A8BLT)
UPPER ARM BLOOD PRESSURE MONITOR(Model No.:FDBP-A4)
UPPER ARM BLOOD PRESSURE MONITOR(Model No.:FDBP-A15)
VeriSmart Health Wireless Upper Arm Smart Blood Pressure Monitor VSH-B550,
Abdominal Fitness Belt, Model FDES107(ED407);
Pain Relief Plaster(Model:FDES105,FDES105B,FDES105C,WMTTENS-90J,TENS-90J)
TENS/EMS/Massage 3In1 Electrical Stimulators FDES101B
Multi-function Mini TENS&EMS device,model FDES106A;
Mini TENS&EMS device,model FDES106(ED406);
TENS & EMS Pain Therapy Device (Model: WMTTENS-100,WMTTENS-100A); Electrical stimulator (Model: FDES190)
TENS & EMS Dual pad (Model:FDES108)
TENS & EMS Pain Therapy Device (Model: FDES191,TENS-150J,TENS-150J-CA,WMTTENS-150J)
blood pressure cuff
FDAC4122
Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030,IRT3030AP,IRT3030US,IRT3030EE,IRT3030WE;
Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030LA,IRT3030EEPBX,IRT3030WEPBX; Braun ThermoScan 4
Braun; Braun ThermoScan® 4 Ear Thermometer IRT3515; Braun ThermoScan® 4 Ear Thermometer IRT3515US,IRT-3515; IRT-3515US
Braun ThermoScan® 4 Ear Thermometer(FDIR-V35,BIT3515CTUS)
Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030US,IRT3030USV1)
Braun ThermoScan® 4+ connect(Model:IRT3575,IRT3575US)
Upper arm Blood pressure monitor (Model: BUA4000BUS,BUA4075BUS)
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A15,FDBP-A16,FDBP-A17,FDBP-A18,FDBP-A19,FDBP-A20,FDBP-A21)
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A1,FDBP-A2,FDBP-A3,FDBP-A4,FDBP-A5,FDBP-A6,FDBP-A7)
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A8,FDBP-A9,FDBP-A10,FDBP-A11,FDBP-A12,FDBP-A13,FDBP-A14)
Upper Arm Blood Pressure Monitor(model number:BPA-800-WT)
Upper arm blood pressure monitor (ModelExactFit 1E, BUA4000US)
Upper arm blood pressure monitor(Model:ExactFit 2,BUA4050US)
FDES100(ED400) Electrical Stimulator
TENS & EMS Dual pad FDES108A; 4 CHANNELS TENS&EMS Stimulator FDES113A
HEAT StimPlus FDES115A;TENS&EMS Electrical Stimulators FDES116A
FDES101(ED401) TENS and EMS Stimulator, FDES102(ED402) TENS Stimulator, FDES103(ED403) EMS Stimulator;
InTemp Basal Thermometer (Model: FDTH-V0-13)
Basal Body Thermometer((Model:BBT-127)
Digital Clinical Thermometer(Model:FDTH-V0-1,FDTH-V0-2,FDTH-V0-3,FDTH-V0-4,FDTH-V0-5,FDTH-V0-6,FDTH-V0-7, FDTH-V0-8)
INFRARED EAR & FOREHEAD THERMOMETER(Model:MYBTIE-500,FDIR-V37)
Easy@Home Dual Digital Thermometer (Model:EBT-013,FDTH-V0-13)
Digital Clinical Thermometer (Model:FDTH-V0-9,FDTH-V0-11,FDTH-V0-12,FDTH-V0-13,FDTH-V0-14,FDTH-V0-15,FDTH-V0-16)
Wireless smart Thermometer (Model: FDTH3409 FDTH3410,FDTH3411)
Infrared thermometer (Model:FDIR-V1, FDIR-V2, FDIR-V3, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V8, FDIR-V9, FDIR-V10)
Infrared thermometer ( FDIR-V11, FDIR-V12, FDIR-V13, FDIR-V14, FDIR-V15, FDIR-V16, FDIR-V17,FDIR-V22,FDIR-V23)
non-contact mini infrared thermometer (Model:TIE-050-BABY,TIE-050)
Wireless smart Thermometer (Model: FDTH3400, FDTH3401,FDTH3402,FDTH3403,FDTH3404, FDTH3405,FDTH3406,FDTH3407,FDTH3408)
TENS/EMS/Massage 3In1 Electrical Stimulators FDES116,FDES116B
MicroTENS® Revita,MicroTENS® Omni
Heat StimPlus,model FDES115;FOUR CHANNELS TENS&EMS&MASSAGE DEVICE FDES113
WIRELESS HEAT TENS UNIT for relieving period pain(Model:FDES123,FDES106)
Electrical Stimulator (Model:FDES112,FDES114,,FDES120,FDES122,FDES124)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)