FDA Registration
Active
🇦🇷 Argentina
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2)
Reg #: 3013145340
·
FEI: 3013145340
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERRAGENE SA
- Registration Number
- 3013145340
- FEI Number
- 3013145340
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ruta Nacional No. 9, Km 280, Parque Industrial Micropi
- City
- Alvear Santa Fe
- Country
- AR
Regulatory Submissions
- 510(k) Number
- K242453
Owner / Operator
- Firm Name
- Terragene SA
- Operator Number
- 10056488
- Address
- Ruta Nacional No 9 km 280,, Parque Industrial Micropi
- City
- Alvear
- State
- Santa Fe
- Postal Code
- 2130
- Country
- AR
US Agent
- Business Name
- Terragene LLC
- Contact Name
- Maximiliano Catalano
- Address
- 25003 Pitkin Rd Ste D800
- City
- Spring
- State
- TX
- ZIP
- 77386
- Country
- US
- [email protected]
- Phone
- 844 8377243
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2025-02-25 |
Proprietary Names
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2)
73140 BIOTRACE Instant Read Steam BI Process Challenge Device
Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
Establishment Types
Manufacture Medical Device