Identity
- Trade Name
- Class I Accessories EUDAMEDAccessory FDA UDI
- Generic Name
- Sterilizer/disinfector rack FDA UDI
- Device Name
- Class I Accessories EUDAMEDAccessory - Injector Cart 2 levels FDA UDI
- Model / Reference
- 6028789401 EUDAMEDInjector Cart 2 levels FDA UDI
- Description
- Accessory - Injector Cart 2 levels FDA UDI
Identifiers
- Catalog Number
- 6028789401 FDA UDI
- Primary DI / UDI-DI
- 07340153710993 EUDAMEDFDA UDI
- Basic UDI-DI
- 7340153700098E EUDAMED
- FDA Product Code
- MEC FDA UDI
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Sterilizer/disinfector rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6992 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilizer/disinfector rack
Accessory by Getinge Disinfection, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Getinge Disinfection, Inc.
Sources (2)
- FDA UDI 0636cb83-7361-4a7b-b1bd-d81585f69093 34 fields · synced Jun 18, 2026
- EUDAMED 6062cb4a-d0ea-464a-a3a5-bca4abdd4667 61 fields · synced Jun 18, 2026