FDA Registration
Active
🇨🇳 China
Disposable Airways Tertiary Balloon Dilatation Catheter, 10551000, 12551000, 12301000, 15551000, 18551000
Reg #: 3036999984
·
FEI: 3036999984
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SUZHOU AMATHES MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3036999984
- FEI Number
- 3036999984
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 4, Xinhong Industrial Park, 9 Suhong West Road, Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Suzhou Amathes Medical Technology Co., Ltd.
- Operator Number
- 10092768
- Address
- Building 4, Xinhong Industrial Park, 9 Suhong West Road, Suzhou Industrial Park
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215000
- Country
- CN
- Correspondent
- Wenjian Dou
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St. Wu
- Address
- 1942 Broadway Ste 314c
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 2025-02-17 |
Proprietary Names
Disposable Airways Tertiary Balloon Dilatation Catheter, 10551000, 12551000, 12301000, 15551000, 18551000
Disposable Airways Tertiary Balloon Dilatation Catheter, 06301000, 06551000, 08301000, 08551000, 10301000
Establishment Types
Manufacture Medical Device