FDA Registration
Active
🇨🇳 China
COVER PROBE W/GEL & BANDS
Reg #: 3013429557
·
FEI: 3013429557
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.
- Registration Number
- 3013429557
- FEI Number
- 3013429557
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3rd Road Linjiang Industrial Zone, Jiangdong New Area
- City
- Heyuan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221278
Owner / Operator
- Firm Name
- Heyuan Hong De Medical Products Co., Ltd.
- Operator Number
- 10052554
- Address
- 3rd Road Industrial Zone of Linjiang, Zijin County
- City
- Heyuan
- State
- Guangdong
- Postal Code
- 517001
- Country
- CN
- Correspondent
- Kevin Yuan
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Road
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-04-12 |
Proprietary Names
COVER PROBE W/GEL & BANDS
Establishment Types
Repack or Relabel Medical Device