Identity
- Trade Name
- Sterilization Cassette EUDAMEDOticon Medical FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Sterilization Cassette EUDAMEDFDA UDI
- Model / Reference
- M52074 EUDAMEDFDA UDI
- Description
- Sterilization cassette FDA UDI
Identifiers
- Catalog Number
- M52074 FDA UDI
- Primary DI / UDI-DI
- 05712149008285 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712149100198M EUDAMED
- Direct Marketing DI
- 05712149008285 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sterilizer/disinfector rack
Sterilization Cassette by Oticon Medical AB — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141616 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5712149100198M | Class I | Active |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (3)
- EUDAMED 9d3804d7-bdbb-43c4-bc91-78eaae1607fc 61 fields · synced Jul 17, 2026
- FDA UDI cc343547-fc10-4538-a4f1-b372a4f611b6 35 fields · synced May 30, 2026
- FDA 510(k) K141616 1 fields · synced May 18, 2026