FDA Registration
Active
🇨🇳 China
Image Processor VLM-02, VLM-03, MS-8, HUV-02
Reg #: 3012797688
·
FEI: 3012797688
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
- Registration Number
- 3012797688
- FEI Number
- 3012797688
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222910
Owner / Operator
- Firm Name
- Shenzhen HugeMed Medical Technical Development Co., Ltd
- Operator Number
- 10052108
- Address
- 401, 501, Building 4, Haizhi Technology Park, Fortis, No.17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518112
- Country
- CN
- Correspondent
- Cathy Shi
US Agent
- Business Name
- Performance International, Inc.
- Contact Name
- Dennis Xu
- Address
- 4004 Pepperton Dr.
- City
- Raleigh
- State
- NC
- ZIP
- 27606
- Country
- US
- [email protected]
- Phone
- 919 8590478
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2023-04-12 |
Proprietary Names
Image Processor VLM-02, VLM-03, MS-8, HUV-02
Single-use Bronchoscope BR-M58, BR-M52, BR-M50, BR-M40, BR-M32, BR-M22, BR-M25, BR-M58H, BR-M52H, BR-M40H,BR-M42,BR-M30;
Establishment Types
Manufacture Medical Device