FDA Registration
Active
🇨🇳 China
MD3000, MD3010, MD3020, MD3030, MD3040, MD3050, MD3001, MD3011, MD3021, MD3031, MD3041, MD3051
Reg #: 3009155917
·
FEI: 3009155917
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
- Registration Number
- 3009155917
- FEI Number
- 3009155917
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152483
Owner / Operator
- Firm Name
- Grandway Technology (Shenzhen) Limited
- Operator Number
- 10036359
- Address
- No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- Patrick Chow
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2015-10-15 |
Proprietary Names
MD3000, MD3010, MD3020, MD3030, MD3040, MD3050, MD3001, MD3011, MD3021, MD3031, MD3041, MD3051
MD3100, MD3110, MD3120, MD3130, MD3140, MD3150, MD3101, MD3111, MD3121, MD3131, MD3141, MD3151
Establishment Types
Manufacture Medical Device