FDA Registration
Active
🇨🇳 China
Easy Comfort Lancets
Reg #: 3006899020
·
FEI: 3006899020
·
Expires 2025
Products
2
Proprietary Names
5
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- HUAIAN HENING MEDICAL INSTRUMENTS CO ., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD
- Registration Number
- 3006899020
- FEI Number
- 3006899020
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.6 West Hongdou Road Economic Development Zone
- City
- Huaian Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223314
Owner / Operator
- Firm Name
- HOME AIDE DIAGNOSTICS, INC.
- Operator Number
- 9087599
- Address
- 1072 S. Powerline Rd., --
- City
- Deerfield Bch
- State
- FL
- Postal Code
- 33442
- Country
- US
- Correspondent
- AMGAD - GIRGIS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-02-03 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-02-03 |
Proprietary Names
Easy Comfort Lancets
True Comfort Pro Lancets
True Comfort Lancets
Pro Comfor Lancets
Pure Comfort Lancets
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device