FDA Registration
Active
🇨🇳 China
Zhangzhou iHastek Inc.
Reg #: 3010186069
·
FEI: 3010186069
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Zhangzhou iHastek Inc.
- Registration Number
- 3010186069
- FEI Number
- 3010186069
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 10 Jinda Road, Wanlida Industry Zone
- City
- Zhangzhou City Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Zhangzhou iHastek Inc.
- Operator Number
- 10042566
- Address
- No. 10 Jinda Road, Wanlida Industry Zone
- City
- Zhangzhou City
- State
- Fujian
- Postal Code
- 363000
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2012-12-07 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-14 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-26 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-14 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-24 |
Proprietary Names
Holmes humidifier
Claritin humidifier
Sunbeam humidifier
Bionaire humidifier
Therapure humidifier
HoMedics humidifier
Mainstays humidifier, HU00-19013B, HU00-19054, H12-01
Humidifier
KN95 masks/Non-powered air-purifying particle masks/Disposable face masks, YW9501,YW9502
KN95 Masks/Non-powered air-purifying particle masks/Disposable face masks, YW9501, YW9502, KN95
Disposable Mask, KN95 Mask, Non-powered air-purifying particle mask, YW9501, YW9502
Establishment Types
Manufacture Medical Device