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
Multiple Use Blood Lancet For Single Patient Use Only QRL
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

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