Identity
- Trade Name
- Dermascan C Ver. 3 USB FDA UDI
- Generic Name
- Ultrasound imaging system operator console FDA UDI
- Device Name
- Ultrasound imaging system main unit FDA UDI
- Model / Reference
- 08 FDA UDI
- Description
- Ultrasound imaging system main unit FDA UDI
Identifiers
- Catalog Number
- A0390008 FDA UDI
- Primary DI / UDI-DI
- 05710188039000 FDA UDI
- 510(k) Number
- K983945 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Ultrasound imaging system operator console FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- 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
No
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
No
FDA UDI
Category: Ultrasound imaging system operator console
Dermascan C Ver. 3 USB by Cortex Technology ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasound imaging system operator console.
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Cortex Technology ApS
Sources (1)
- FDA UDI b8e804ab-755d-422a-8d36-b165a93dc8b4 36 fields · synced Jun 6, 2026