FDA Registration
Active
🇹🇼 Taiwan
Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #5
Reg #: 8043316
·
FEI: 3003319165
·
Expires 2025
Products
1
Proprietary Names
63
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, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2004-09-15 |
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