FDA Registration
Active
🇨🇳 China
Piston Compress Nebulizer -JLN-2312AS(MQ6002), JLN-2313AS(18070), JLN-2318AS(18080), JLN-2337AS(MQ5600)
Reg #: 3010287621
·
FEI: 3010287621
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN HOMED MEDICAL DEVICE CO LTD
- Registration Number
- 3010287621
- FEI Number
- 3010287621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 1601-1614, A Building , Jinxiu III, No.85 Hudi Pai, Songxuan Community, Guanhu Street, Longhua District
- City
- Shenzhen city Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K161586
Owner / Operator
- Firm Name
- Jarlung(H.K.)Industries Limited
- Operator Number
- 10041952
- Address
- Room1601to1614,ABuilding,JinxiuIII,No.85HudiPaiSongxuanCommunity,GuanhuStreet,Longhua District,Shenzhen, Shenzhen City Guangdong, CHINA 518109
- City
- shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
- Correspondent
- Shengming Shi
US Agent
- Business Name
- CTI US lnc.
- Contact Name
- Robin Zhang
- Address
- 1455 Lincoln Pkwy E Ste 230
- City
- Atlanta
- State
- GA
- ZIP
- 30346
- Country
- US
- [email protected]
- Phone
- 313 2885666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2017-12-25 |
Proprietary Names
Piston Compress Nebulizer -JLN-2312AS(MQ6002), JLN-2313AS(18070), JLN-2318AS(18080), JLN-2337AS(MQ5600)
Piston Compress Nebulizer - JLN-2317AS(MQ5800), JLN-2320AS,JLN-2305BS-B(MQ6000),JLN-2305BS,JLN-2322AS
Piston Compress Nebulizer -JLN-2319AS, JLN-2342AS(MQ6005),JLN-2300AS,JLN-2301AS,JLN-2309AS,JLN-2360AS
Piston Compress Nebulizer -JLN-2341AS(MQ6003), JLN-2343AS(18090-BE),JLN-2310AS(18090-FS), JLN-2308AS(3050-2)
Piston Compress Nebulizer - JLN-2300Air, JLN-2305AS, JLN-2302AS, JLN-2300BS, JLN-2315AS,JLN-2362AS,JLN-2311HD
Piston Compress Nebulizer - JLN-2305HD
Piston Compressor Nebulizer-JLN-2301HD
JLN-2308AS(3050-3NDS)
JLN-2308AS(3050-2NDS)
Piston Compress Nebulizer -JLN-2318Air
Establishment Types
Manufacture Medical Device