Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGETINGE IC PRODUCTION POLAND SP Z O O
US
Last updated May 23, 2026
What GETINGE IC PRODUCTION POLAND SP Z O O makes
The company manufactures steam sterilizers, including models such as the Getinge 700 Series, 500 Series, and 400 Series, designed for medical and healthcare environments to sterilize surgical instruments and equipment using steam under pressure.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Getinge IC Production Poland Sp. Z O.O. manufacture?
Getinge IC Production Poland Sp. Z O.O. specializes in steam sterilizers, such as the Getinge 700 Series, 500 Series, and 400 Series. These devices are engineered for medical and healthcare settings to ensure the sterilization of surgical instruments and equipment using pressurized steam, which is a critical process for infection control.
Where is Getinge IC Production Poland Sp. Z O.O. based?
The company is based in the United States. While the name includes 'Poland,' the operational headquarters and primary manufacturing presence are located in the US, where its devices are designed and produced.
Which regulatory registries list the devices manufactured by Getinge IC Production Poland Sp. Z O.O.?
The devices produced by Getinge IC Production Poland Sp. Z O.O., such as the Getinge 700, 500, and 400 Series steam sterilizers, are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US market.
How are the devices manufactured by Getinge IC Production Poland Sp. Z O.O. classified under FDA regulations?
The steam sterilizers produced by Getinge IC Production Poland Sp. Z O.O. fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 427370513
Catalogue (350)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 400 Series | 433HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 400 Series | 433HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 400 Series | 433HC | FDA UDI | Class II | Active |
| Getinge 800 Series | 833HC | FDA UDI | Class II | Unknown |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 400 Series | 433HC | FDA UDI | Class II | Active |
| Getinge 800 Series | 833HC | FDA UDI | Class II | Unknown |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 600 Series | 633HC | FDA UDI | Class II | Unknown |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 500 Series | 533HC | FDA UDI | Class II | Active |
| Getinge 400 Series | 433HC | FDA UDI | Class II | Active |
| Getinge 700 Series | 733HC | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.