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
Phone
512 3279997

Products

Device Name Product Code
Mask, Oxygen BYG

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)