FDA Registration
Active
🇨🇳 China
Luna G3 BPAP System
Reg #: 3026086583
·
FEI: 3026086583
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BMC (Tianjin) Medical Co., Ltd.
- Registration Number
- 3026086583
- FEI Number
- 3026086583
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building C20, Venture Headquarters Base, No.18 Fuyuan Street
- City
- Wuqing District Tianjin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212263
Owner / Operator
- Firm Name
- BMC Medical Co., Ltd
- Operator Number
- 10040296
- Address
- Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road
- City
- Fengtai District
- State
- Beijing
- Postal Code
- 100073
- Country
- CN
- Correspondent
- Fang Zheng
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301, Bellingham, Washington, 98226, UNITED STATES
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2022-03-30 |
Proprietary Names
Luna G3 BPAP System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility