Identity
- Trade Name
- Getinge 400 Series FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Steam Sterilizer - 433HC-E,L1,SD,DU,VP,PWR,R2 FDA UDI
- Model / Reference
- 433HC FDA UDI
- Description
- Steam Sterilizer - 433HC-E,L1,SD,DU,VP,PWR,R2 FDA UDI
Identifiers
- Catalog Number
- 4SSRUPHRAAAA FDA UDI
- Primary DI / UDI-DI
- 05902533500154 FDA UDI
- 510(k) Number
- K122071 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Steam sterilizer
Getinge 400 Series by Getinge Ic Production Poland Sp Z O O — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Steam sterilizer.
- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC. · Class II
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
- STATIM 5000 G4 Cassette Autoclave — Scican GmbH · Class II
- Integrity Sterilizers — Skytron, LLC · Class II
- PRIMUS Sterilizer — PRIMUS STERILIZER COMPANY, LLC. · Class II
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class II
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
Cleared under the same submission
K122071 also covers:
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O O
- Getinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O O
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Getinge Ic Production Poland Sp Z O O
Sources (1)
- FDA UDI e56f7b50-b770-43bf-899e-78031d11d96f 35 fields · synced May 30, 2026