FDA Registration
Active
🇹🇼 Taiwan
AM-2 Aerosol Mask, Adult
Reg #: 8043316
·
FEI: 3003319165
·
Expires 2025
Products
1
Proprietary Names
28
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GALEMED CORP.
- Registration Number
- 8043316
- FEI Number
- 3003319165
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.87, LI-GONG 2ND RD.,
- City
- WU-JIA Yilan
- Country
- TW
Owner / Operator
- Firm Name
- GaleMed Corporation
- Operator Number
- 8043316
- Address
- 87, LI-GONG 2ND RD.,
- City
- Wu-jia
- State
- Yilan
- Postal Code
- 268
- Country
- TW
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2007-03-14 |
Proprietary Names
AM-2 Aerosol Mask, Adult
OM-1 Mask, Infant w/Tubing
AM-2 HiO2 Mask, Adult
AM-2 Oxygen Mask, Adult
Venturi, 50% O2, 22M, Orange
TM-1 Trachea Mask, Adult w/Tubing
OM-1 Mask, Adult
OM-1 HiO2 Mask, Infant w/Tubing
Venturi, 35% O2, 22M, Green
OM-2 Hi-O2 Mask, Adult
Venturi, 40% O2/8LPM, 22M, Red
OM-5 face Tent w/Tubing
LAV Venturi Mask Kit, Adult
Adj Venturi (LAV) Adaptor, 22F
AM-3 Adj-Venturi Mask, Child w/Tube
OM-3 HiO2 Mask, Child w/Tubing, PVC Bag
OM-2 HiO2 Mask, Child
M1 HiO2 Mask, L
M1 Oxygen Mask, M
Venturi, 24% O2, 22M, Blue
OM-2 PR-Mask, Adult w/Tubing
Venturi, 28% O2, 22M, Yellow
Venturi, 50% O2, 22F, Orange
AM-3 Venturi Mask, Adult
Venturi, 31% O2, 22M, White
GALEMED MASK
AM-2 Aerosol Mask, Child
NASAL CPAP MASK
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)