FDA Registration
Active
🇨🇳 China
Hetaida Technology Co., Ltd.
Reg #: 3017493034
·
FEI: 3017493034
·
Expires 2026
Products
8
Proprietary Names
50
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- Hetaida Technology Co., Ltd.
- Registration Number
- 3017493034
- FEI Number
- 3017493034
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road,, Liaobu Town, Dongguan City, Guangdong Province
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200781
Owner / Operator
- Firm Name
- HeTaiDa Technology Co., Ltd
- Operator Number
- 10058025
- Address
- Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road,, Liaobu Town, Dongguan City, Guangdong Province
- City
- DongGuan
- State
- Guangdong
- Postal Code
- 523423
- Country
- CN
- Correspondent
- Tom Chen
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-12-13 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2025-06-11 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2024-02-20 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2026-06-12 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-02-10 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2024-07-14 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-01-13 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2026-03-31 |
Proprietary Names
Infrared Body Thermometer, model: HTD8222US
Infrared Body Thermometer, model: HTD8219US
Behind-the-Ear Hearing Aid, model: HTD6102US
Upside Down Peri Bottle, Model: K5101US; Peri Bottle, Model: K5102US
In-The-Ear Digital Hearing Aids, model: H6103US
Electronic Blood Pressure Monitor, Model: D6606US, D6607US
HTD8816C
HTD8808C
HTD8819C
HTD8818A
HTD8813C
VNT275US
VNT275USV1
VNT275CA
VNT275CAV1
HTD8812C
HTD8818D
Infrared Body Thermometer, model: HTD8823US, K8832US, H8831US
HTD8216C
H8228US
Electronic blood pressure monitor, model: HTD6601US; HTD6602US; HTD6603US; HTD6605US; D6606US; D6607US
HTD2602US
H2609AU
NA-002
H2605US
H2609US
H2606US
H2603US
HTD2601US
VIEK HTD8816C
VTEK HTD8816C
H8830US
K8832US
HTD8220US
HTD8823US
HTD8219US
HTD8208C
HTD8210US
H8831US
HTD8222US
T8850US
Infrared Ear Thermometer, model: HTD8208C
Infrared Body Thermometer, model: HTD8220US
Postpartum Essentials Care Kit, model: 5M01
BNT100US
BNT100
VNT200
VNT200US
BNT100CA
BNT100CAV1
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)