FDA Registration
Active
🇨🇳 China
SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD
Reg #: 3011716786
·
FEI: 3011716786
·
Expires 2026
Products
8
Proprietary Names
2
Establishment Types
3
Classifications
8
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Registration Details
- Registration Name
- SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD
- Registration Number
- 3011716786
- FEI Number
- 3011716786
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 10, Xinqiao GangZai Road, Xinqiao Street, BaoAn District
- City
- Shenzhen City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K091272
Owner / Operator
- Firm Name
- Shenzhen Bi-Rich Medical Devices Co., Ltd.
- Operator Number
- 10049196
- Address
- No.10, Xinqiao GanZai Road, Xingiao Street, Bao'An District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518125
- Country
- CN
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Rd
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2021-01-06 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2025-11-17 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2016-08-19 |
| Vacuum Powered Body Fluid Collection Kit | OJR | Class 2 | General, Plastic Surgery | No | 2021-04-23 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2021-05-19 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2021-01-06 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2015-04-27 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2025-06-02 |
Proprietary Names
Nebulizer
Compressor Nebulizer
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)