FDA Registration
Active
🇨🇳 China
ONE Drop Lancing Device
Reg #: 3002773714
·
FEI: 3002773714
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- JETCROWN INDUSTRIAL (DONG GUAN) LTD.
- Registration Number
- 3002773714
- FEI Number
- 3002773714
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HUANGANG INDUSTRIAL ESTATE, HOUJIE TOWN, DONG GUAN CITY
- City
- GUANGDONG PROVINCE
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223815
Owner / Operator
- Firm Name
- JETCROWN INDUSTRIAL (DONG GUAN) LTD.
- Operator Number
- 9042369
- Address
- HUANGANG INDUSTRIAL ESTATE, HOUJIE TOWN, DONG GUAN CITY
- City
- GUANGDONG PROVINCE
- State
- CN-NOTA
- Postal Code
- 523946
- Country
- CN
US Agent
- Business Name
- STAT Medical Devices
- Contact Name
- Steven Schraga
- Address
- 2056 NE 153rd Street
- City
- North Miami Beach
- State
- FL
- ZIP
- 33162
- Country
- US
- [email protected]
- Phone
- 305 9450011
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 | 2023-02-17 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-02-17 |
Proprietary Names
ONE Drop Lancing Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)