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
Phone
919 8590478

Products

Device Name Product Code
Bronchoscope (Flexible Or Rigid) EOQ

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