FDA Registration Active 🇨🇳 China

Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #5

Reg #: 3006783791 · FEI: 3006783791 · Expires 2025
Products
1
Proprietary Names
63
Establishment Types
2
Classifications
1

Registration Details

Registration Name
GaleMed (Xiamen) Co., Ltd.
Registration Number
3006783791
FEI Number
3006783791
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road, 361026 Fujian Province, China
City
XIAMEN Fujian
Country
CN

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
ProMedic, LLC
Contact Name
Matt Dryden
Address
131 Bay Point Dr. NE, St. Petersburg, FL 33704, USA
City
Saint Petersburg
State
FL
ZIP
33704
Country
US
Phone
239 3076060

Products

Device Name Product Code
Mask, Gas, Anesthetic BSJ

Proprietary Names

Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #5 Ambu Open Cuff Silicone Face Mask Reusable mask Silicone mask Economy reusable mask SURE SEAL ANESTHETIC MASK Aircushion Mask Size 3 Airsoft Mask, #1 w/Valve SURE SEAL® Air Cushion Mask, w/ Valve, Med Adult SURE SEAL® Air Cushion Mask, Sm Adult/Youth SURE SEAL® Air Cushion Mask, Infant Endo Mask, L w/Harness Airsoft Mask, #0 Air-SoftTM Mask Size 5, Adult Large, w/Valve Aircushion Mask Size 5 Rendell Baker Silicone Mask, #0 Airsoft Mask, #3 w/Valve RESUSCITATION MASK LARGE ADULT SURE SEAL® Air Cushion Mask, w/ Valve, Infant Mask LiteStar5 w/o hook AIR SOFT MASK, SIZE 1 Mask LiteStar6 w/o hook Headgear disp.,soft fabric,la. SURE SEAL® Air Cushion Mask, Large Adult Airsoft Mask, #1 SURE SEAL® Air Cushion Mask, w/ Valve, Sm Adult/Youth Airsoft Mask, #4 w/Valve RESUSCITATION MASK LARGE INFANT SURE SEAL® Air Cushion Mask, w/ Valve, Ped/Toddler Air-SoftTM Mask Size 1, Infant Large, w/Valve SURE SEAL® Air Cushion Mask, Med Adult Mask LiteStar2 w/o hook Hook ring for LiteStar masks with 15mm connector Mask LiteStar3 w/o hook Headgear disp.,soft rub.,small Headgear disp.,soft rub.,large Air-SoftTM Mask Size 3, Child Large, w/Valve SURE SEAL® Air Cushion Mask, Ped/Toddler RESUSCITATION MASK SMALL ADULT Airsoft Mask, #4 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #0 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #2 Airsoft Mask, #0 w/Valve AirLifeTM AirLife Disposable Face Mask Pediatric Mask LiteStar1 w/o hook Headgear disp.,soft farbic,sm. Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #1 Airsoft Mask, #5 RESUSCITATION MASK LARGE CHILD Air-SoftTM Mask Size 4, Adult, w/Valve SURE SEAL® Air Cushion Mask, Neonate SURE SEAL® Air Cushion Mask, w/ Valve, Neonate Airsoft Mask, #2 w/Valve SURE SEAL® Air Cushion Mask, w/ Valve, Large Adult Airsoft Mask, #3 Airsoft Mask, #5 w/Valve AirLifeTM AirLife Disposable Face Mask Neonate Air-SoftTM Mask Size 2, Child, w/Valve Airsoft Mask, #6 w/Valve Airsoft Mask, #2 Mask LiteStar4 w/o hook Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #3 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #4

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device