FDA Registration
Active
🇵🇱 Poland
Models 8666, 8668, S-8668T
Reg #: 3031563141
·
FEI: 3031563141
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GETINGE AB
- Registration Number
- 3031563141
- FEI Number
- 3031563141
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KOPANINA 30A
- City
- POZNAN Wielkopolskie
- Country
- PL
Owner / Operator
- Firm Name
- Getinge AB
- Operator Number
- 10090886
- Address
- Kopanina 30A
- City
- Poznan
- State
- Wielkopolskie
- Postal Code
- PL 60-105
- Country
- PL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2024-08-05 |
Proprietary Names
Models 8666, 8668, S-8668T
Models 9120, 9122, 9125 and 9128
Aquadis 56 washer disinfector
Models 46-4, 46-5
Model CM320
Getinge Aquadis Index
Models 9120E, 9122E, 9125E, 9127E, 9128E, 9128EW
Establishment Types
Complaint File Establishment per 21 CFR 820.198