Identity
- Trade Name
- MONO Surgery Kit EUDAMEDPonto FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- MONO kit EUDAMEDMONO Surgery Kit FDA UDI
- Model / Reference
- 220701 EUDAMEDFDA UDI
- Description
- MONO Surgery Kit FDA UDI
Identifiers
- Catalog Number
- 220701 FDA UDI
- Primary DI / UDI-DI
- 05712149026302 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712149100148B EUDAMED
- FDA Product Code
- MAH FDA UDI
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- ENT surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MONO Surgery Kit by Oticon Medical AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5712149100148B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED 194d1ddd-0d0e-4930-9ddb-57a3d05355f5 61 fields · synced Jul 27, 2026
- FDA UDI 99b2a37e-4400-438c-a346-3d5542d11992 35 fields · synced May 27, 2026