Identity
- Trade Name
- DermoSight Software FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- Web-based software for dermatoscope image capture and analysis FDA UDI
- Model / Reference
- DXH-SW-100 FDA UDI
- Description
- Web-based software for dermatoscope image capture and analysis FDA UDI
Identifiers
- Catalog Number
- DXH-SW-100 FDA UDI
- Primary DI / UDI-DI
- 00860013961411 FDA UDI
- FDA Product Code
- PSN FDA UDI
- GMDN Term
- Dermatoscope, optical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatoscope, optical
DermoSight Software by Deepx Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatoscope, optical.
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- Diagnostix™ — American Diagnostic Corporation · Class I
- DermLite DL1 — DermLite LLC · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- HEINE diSTANCE — Heine Optotechnik GmbH & Co. KG · Class I
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
- Deepx Health, LLC
Sources (1)
- FDA UDI 997012b1-476a-4e59-bf6d-2b0ffdaf9bda 34 fields · synced Jun 8, 2026