Identity
- Trade Name
- Getinge 500 Series FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Steam Sterilizer - 533HC-E,L1,SD,DU,PWR,R2,208BD FDA UDI
- Model / Reference
- 533HC FDA UDI
- Description
- Steam Sterilizer - 533HC-E,L1,SD,DU,PWR,R2,208BD FDA UDI
Identifiers
- Catalog Number
- 5SSVUPHRA1AA FDA UDI
- Primary DI / UDI-DI
- 05902533502059 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 500 Series by Getinge Ic Production Poland Sp Z O O — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 400 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 |
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Manufacturer
- Manufacturer
- Getinge Ic Production Poland Sp Z O O
Sources (1)
- FDA UDI 33743cec-ad20-4231-9109-29a050b21d48 35 fields · synced May 30, 2026