Identity
- Trade Name
- Softband 5, Unilateral XS/S Beige EUDAMEDPonto FDA UDI
- Generic Name
- Head-worn bone-conduction hearing aid holder, reusable FDA UDI
- Device Name
- Softband EUDAMEDSoftband 5, Unilateral XS/S Beige FDA UDI
- Model / Reference
- 227693 EUDAMEDFDA UDI
- Description
- Softband 5, Unilateral XS/S Beige FDA UDI
Identifiers
- Catalog Number
- 227693 FDA UDI
- Primary DI / UDI-DI
- 05712149026630 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491000386 EUDAMED
- FDA Product Code
- LXB FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Head-worn bone-conduction hearing aid holder, reusable FDA UDI
Classification
- Device Class
- Class I 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
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
Softband 5, Unilateral XS/S Beige by Oticon Medical AB — Class I — 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 | 57121491000386 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED 3f29e024-c949-4698-a03e-2628a07c6b7a 61 fields · synced Jun 18, 2026
- FDA UDI e028e621-3d07-4faf-8f7f-1b9678f0947d 35 fields · synced May 30, 2026