FDA Registration
Active
🇨🇳 China
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
Reg #: 3013443304
·
FEI: 3013443304
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- EXACT MEDICAL MANUFACTURING, INC.
- Registration Number
- 3013443304
- FEI Number
- 3013443304
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21# Qingjiang Road
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K121919
Owner / Operator
- Firm Name
- Exact Medical Manufacturing, Inc.
- Operator Number
- 10053949
- Address
- 21# Qingjiang Road
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213022
- Country
- CN
- Correspondent
- Ryan Power
US Agent
- Business Name
- Exact Medical Manufacturing, Inc.
- Contact Name
- Ryan Power
- Address
- 4917 William St Ste C
- City
- Lancaster
- State
- NY
- ZIP
- 14086
- Country
- US
- [email protected]
- Phone
- 716 6810076
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical | KKX | Class 2 | General, Plastic Surgery | No | 2017-01-25 |
Proprietary Names
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device