FDA Registration
Active
🇦🇷 Argentina
GraphNet TS
Reg #: 3009302812
·
FEI: 3009302812
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tecme SA
- Registration Number
- 3009302812
- FEI Number
- 3009302812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av. Circunvalacion (N-O) Agustin Tosco 3040
- City
- Cordoba
- Country
- AR
Regulatory Submissions
- 510(k) Number
- K111595
Owner / Operator
- Firm Name
- Tecme S.A.
- Operator Number
- 10034919
- Address
- Av. Circunvalacion (N-O) Agustin Tosco 3040
- City
- Cordoba
- State
- AR-X
- Postal Code
- X5008HJY
- Country
- AR
- Correspondent
- Ernesto M Mana Escuti
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 |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2012-05-06 |
Proprietary Names
GraphNet TS
GraphNet Advance
GraphNet Neo
Neumovent Schiller GraphNet Neo
Neumovent Schiller GraphNet Advance
Neumovent GraphNet Neo
Neumovent Schiller GraphNet Ts
Neumovent GraphNet Advance
Neumovent GraphNet Ts
Establishment Types
Manufacture Medical Device