FDA Registration
Active
🇨🇳 China
HG5-W-NS Oxygen Concentrator
Reg #: 3007307467
·
FEI: 3007307467
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENYANG CANTA MEDICAL TECH. CO., LTD
- Registration Number
- 3007307467
- FEI Number
- 3007307467
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 2-1 PUYU ROAD, SHENBEI NEW DISTRICT, SHENYANG, LIAONING PROVINCE, CHINA
- City
- Shengyang Liaoning
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K081508
Owner / Operator
- Firm Name
- Shenyang Canta Medical Tech. Co., Ltd
- Operator Number
- 10027198
- Address
- No.2-1 Puyu Road, Shenbei New District, Shenyang, Liaoning Province, People's Republic of China
- City
- Shengyang
- State
- Liaoning
- Postal Code
- 110136
- Country
- CN
- Correspondent
- Xiaobo Zhu
US Agent
- Business Name
- Mid-link International, INC
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2008-10-12 |
Proprietary Names
HG5-W-NS Oxygen Concentrator
HG5-WN-NS Oxygen Concentrator
Establishment Types
Manufacture Medical Device