FDA Registration
Active
🇨🇳 China
SHENZHEN HOMED MEDICAL DEVICE CO LTD
Reg #: 3010287621
·
FEI: 3010287621
·
Expires 2026
Products
11
Proprietary Names
28
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- SHENZHEN HOMED MEDICAL DEVICE CO LTD
- Registration Number
- 3010287621
- FEI Number
- 3010287621
- Status
- Active
- Expiry Year
- 2026
- 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
- K252616
Owner / Operator
- Firm Name
- Shenzhen Homed Medical Device Co., Ltd
- 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, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2020-07-12 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2024-01-26 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-01-29 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2024-11-04 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2026-02-04 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2023-06-05 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2019-01-14 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2019-01-14 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2024-01-26 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2025-05-16 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2024-11-05 |
Proprietary Names
Nebulizer ,JLN-S07(6910P)
BYX - TUBING, PRESSURE AND ACCESSORIES
mask
mouthpiece
Portable Oxygen Generator,JLO-190P,JLO-190PL
Suction Cannister kit
Nebulizer
Compressor Nebulizer
MQ5900,MQ5900P
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
JLN-2308AS(3050-3NDS)
Piston Compressor Nebulizer-JLN-2301HD
Piston Compress Nebulizer - JLN-2305HD
Piston Compress Nebulizer-JLN-2318Air,JLN-2361Air
JLN-2308AS(3050-2NDS)
Piston Compress Nebulizer-570-5616(JLN-2318AS)
GAZ - TUBING, NONINVASIVE
Nasal spray, ENT dclivery
nasal oxygen cannula
Mesh Nebulizer-JLN-MB001,JLN-MB002,JLN-MB003,JLN-MB004,JLN-MB005,JLN-MB006,JLN-MB007
Curelief Purabreathe Mesh Nebulizer
Mesh Nebulizer- UN200
Nebulizer-JLI
Nebulizer-JLM,JLK,JLH,JLD
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device