FDA Registration
Active
🇲🇽 Mexico
STERILE WATER & SALINE IN PLASTIC BTL.
Reg #: 3005440755
·
FEI: 3005440755
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Laboratorios PISA S.A. de C.V.
- Registration Number
- 3005440755
- FEI Number
- 3005440755
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE 7, N0. 1308 ZONA INDUSTRIAL
- City
- GUADALAJARA Jalisco
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K800753
Owner / Operator
- Firm Name
- Laboratorios PiSA S.A. de C.V
- Operator Number
- 9079024
- Address
- Av. Espana No 1840, Col. Moderna
- City
- Guadalajara
- State
- Jalisco
- Postal Code
- 44190
- Country
- MX
US Agent
- Business Name
- Pisa Manufacturing Inc
- Contact Name
- Raza Mohammed
- Address
- 300 GREAT OAKS BLVD
- City
- ALBANY
- State
- NY
- ZIP
- 12203
- Country
- US
- [email protected]
- Phone
- 518 9925944
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2010-07-19 |
Proprietary Names
STERILE WATER & SALINE IN PLASTIC BTL.
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)