FDA Registration
Active
🇹🇼 Taiwan
Theta Anesthesia Circuit, 180 cm, Adult
Reg #: 8043316
·
FEI: 3003319165
·
Expires 2025
Products
1
Proprietary Names
41
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 |
|---|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2007-03-14 |
Proprietary Names
Theta Anesthesia Circuit, 180 cm, Adult
Hytrel Ckt, Child, 120cm w/2 Water Trap
Swivel Anesthesia Circuit, Adult
ECO Anesthesia Circuit, Adult
Standard Coaxial Circuit (180cm tubing), Adult
Hytrel Ckt, Child, 120cm w/Water Trap
HBC Adult Breathing Circuit
Hytrel Ckt, Adult, 120cm w/2 Water Trap
Standard Coaxial Circuit (150cm tubing), Adult
Sil.Plus Circuit, Adult w/2 Water Trap
Disposable respiratory circuit
Disposable anesthesia circuit
Single limb manifold
VENTILATOR CIRCUIT
EVA Circuit, Adult, 180cm w/Mask #4
EVA Single Limb Circuit, 165cm
EVA Circuit, Adult, 180cm
Reusable Breathing Circuit, Single Limb
Silicone Single Limb Circuit, Adult
Vent Set Basic
Anesth. Set Basic Latexfr.,US
VentStar Basic P 150 w/o LuerL
VentStar Anaesthesia w/o LuerL
Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm
VentStar Anesth (P) w/o. LuerL
Anesthesia set Flex, latexfree
Silicone J-Circuit, Adult
CV-1 Manifold w/L-Cap
Disposable Respiratiory Circuit, Single Limb
EVA Single Limb Circuit, 165cm w/WT
Manifold, 2 way, PSF
Theta Circuit, 180cm
Anesthesia set Basic, latexfree
Manifold, 3 Way, PSF
Vent Set Flex
Hytrel Circuit, Adult w/Water Trap
L Connector, 22F, 22/15mm, PC
Sil.Plus Circuit, Child w/2 Water Trap
Durable Silicone Breathing Circuit with water trap, Adult
Theta Circuit, 150cm
Disposable Tail Valve 12M, 15M
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device