FDA Registration
Active
🇭🇰 Hong Kong
BMC INVESTMENT HOLDING LIMITED
Reg #: 3033530343
·
FEI: 3033530343
·
Expires 2026
Products
3
Proprietary Names
15
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BMC INVESTMENT HOLDING LIMITED
- Registration Number
- 3033530343
- FEI Number
- 3033530343
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROOM 747, 7/F STAR HOUSE, 3 SALISBURY ROAD, TSIM SHA TSUI, KOWLOON,HK
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K112271
Owner / Operator
- Firm Name
- BMC Investment Holding Limited
- Operator Number
- 10091606
- Address
- ROOM 747, 7/F STAR HOUSE, 3 SALISBURY ROAD, TSIM SHA TSUI, KOWLOON,HK
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Chengwei Gao
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- 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 |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2024-10-18 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2024-10-18 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2024-10-18 |
Proprietary Names
Rio II Nasal Pillows Interface
RESmart CPAP and Auto CPAP
RESmart® BPAP 25A
Luna® CPAP and Auto CPAP System
Luna II CPAP and Auto CPAP System; Luna II QX CPAP and Auto CPAP System
Breathing Tube (L1)
BPAP System
Siesta Full Face Mask; Siesta Nasal Mask
Siesta 2 Full Face Mask; Siesta 2 Nasal Mask
Rio II Full Face Mask; Rio II Nasal Mask
Auto CPAP System
F2 Single-Patient Vented Full Face Mask
Viva Nasal Mask; Numa Full Face Mask
Numa II Full Face Mask
Luna G3 BPAP System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device