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Instrument Sterlization Tray, SmartRelease
EUDAMEDFDA UDIClass I (EU MDR)
Ref 83040-CE
Identity
- Trade Name
- Instrument Sterlization Tray, SmartRelease EUDAMEDMicroAire® FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- SmartRelease Accessories EUDAMEDInstrument Sterilization Tray, SmartRelease FDA UDI
- Model / Reference
- 83040-CE EUDAMED83040 FDA UDI
- Description
- Instrument Sterilization Tray, SmartRelease FDA UDI
Identifiers
- Catalog Number
- 83040-CE FDA UDI
- Primary DI / UDI-DI
- 00847399015921 EUDAMEDFDA UDI
- Basic UDI-DI
- 08473990SMARTACCSW9 EUDAMED
- Direct Marketing DI
- 00847399015921 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Italy 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical utensil washer/disinfector
Instrument Sterlization Tray, SmartRelease by MicroAire Surgical Instruments LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Surgical utensil washer/disinfector.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08473990SMARTACCSW9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
- EUDAMED SRN
- US-MF-000004063
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 3aa59a27-f1c5-4d92-8887-9dfd4643b230 61 fields · synced Jul 15, 2026
- FDA UDI f3dd8ad3-20d2-4408-952f-f4f5c260e449 35 fields · synced May 30, 2026