Identity
- Trade Name
- Getinge Aquadis 56 FDA UDI
- Generic Name
- Surgical utensil washer/disinfector FDA UDI
- Device Name
- Getinge Aquadis 56 EUDAMEDWasher disinfector FDA UDI
- Model / Reference
- 56M-001 EUDAMED56M FDA UDI
- Description
- Washer disinfector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340153710351 EUDAMEDFDA UDI
- Basic UDI-DI
- 73401537000484 EUDAMED
- FDA Product Code
- MEC FDA UDI
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
- GMDN Term
- Surgical utensil washer/disinfector FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
FDA UDI
Category: Surgical utensil washer/disinfector
Getinge Aquadis 56 by Getinge Disinfection, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical utensil washer/disinfector.
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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 45dc7e6c-74d6-4bf7-9e30-fc5dd7ca3b86 33 fields · synced Jul 9, 2026
- EUDAMED e8c58dbb-3af5-42b6-9cdc-2177f83eeb4c 61 fields · synced Jul 9, 2026