FDA Registration
Active
🇨🇳 China
L3:Nasogastric tube, nasogastric tube fixed (pediatric single tube)/
Reg #: 3008058406
·
FEI: 3008058406
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Sichuan AST Medical Equipment Co., Ltd
- Registration Number
- 3008058406
- FEI Number
- 3008058406
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.58 ,Jin-Peng Road, C area, Luxian Industrial Park
- City
- Luzhou City Sichuan
- Country
- CN
Owner / Operator
- Firm Name
- Sichuan AST Medical Equipment Co., Ltd
- Operator Number
- 10030716
- Address
- No. 58, Jin-Peng Road, C area, Luxian Industrial Park
- City
- Luzhou City
- State
- Sichuan
- Postal Code
- 646100
- Country
- CN
- Correspondent
- Michelle Chu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2023-08-01 |
Proprietary Names
L3:Nasogastric tube, nasogastric tube fixed (pediatric single tube)/
C2:Catheter and drainage tube fixation (pediatric)/C3:Central venous catheter tracheal intubation fixed/
indwelling needle fixation/B3:Central venous catheter fixation double lumen)/C1:Catheter and drainage tube fixation/
L2:Nasogastric tube, nasogastric tube fixed (double tube)/
Medical Fixation Strap Belt (A1:Catheter fixation (pediatric)/A2:Indwelling needle fixation/A3:Indwelling needle,
Gas cutting fixture(XW2023403)}
central venous catheter fixation/B1:Peripheral IV catheter, indwelling needle fixation/B2:Peripheral IV catheter,
Gas cutting device{Gas cut fixed Strap(XW2023401), Tracheal intubation fixation(XW2023402),
A5:Retention needle fixation (Y type)/A6:Indwelling needle, peripheral IV catheter fixation/A7:Indwelling needle,
C4:Catheter and drainage tube fixation/C5:Central venous catheter tracheal intubation fixed/
central venous catheter fixation/A4:Indwelling needle, peripheral IV catheter fixation/
D2:Peripheral venous catheter fixation patch(Thin film type)/L1:Nasogastric tube,nasogastric tube fixed (single tube)/
L4:Nasogastric tube,nasogastric tube fixed (pediatric double tube))
C6:Central venous catheter tracheal intubation fixed/D1:Peripheral venous catheter fixation patch/
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device