Identity
- Trade Name
- Focus FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Model / Reference
- Focus FDA UDI
Identifiers
- Catalog Number
- 50600 FDA UDI
- Primary DI / UDI-DI
- 06430035872459 FDA UDI
- 510(k) Number
- K001729 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Stationary intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Focus by PaloDEx Group Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PaloDEx Group Oy
Sources (1)
- FDA UDI 90c857fb-aaf7-458c-a417-3713aeaf8616 35 fields · synced May 30, 2026