FDA Registration
Active
🇨🇳 China
CPAP head strap anti-mark pad(XW2023901), Non-slip sleeve for nasal mask(XW2023902), Mask hose protector(XW2023903),
Reg #: 3008058406
·
FEI: 3008058406
·
Expires 2025
Products
1
Proprietary Names
7
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 |
|---|---|---|---|---|---|
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2023-08-01 |
Proprietary Names
CPAP head strap anti-mark pad(XW2023901), Non-slip sleeve for nasal mask(XW2023902), Mask hose protector(XW2023903),
ResMed AirFit F20 Headgear(XW2023103), Dream Wear Headgear(XW2023104), Philips Respironics Wisp Headgear(XW2023105),
Philips Respironics Fit Life Headgear(XW2023106), Philips Respironics Amara view headgear(XW2023107),
Nuance Pro Headgear(XW2023108), Fisher & Paykel Simplus Headgear(XW2023109), Fisher & Paykel Vitera Headgear(XW2023110),
XW2023007/XW2023008/XW2023009), P10 Nasal pillow headband(XW2023101), ResMed AirFit N20 Headgear(XW2023102),
Head strap and accessories(CPAP Strap(XW2023001/XW2023002/XW2023003),CPAP HEADGEAR(XW2023004/XW2023005/XW2023006/
Head strap hook(XW2023904), CPAP mask silicone pad(XW2023905))
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