Identity
- Trade Name
- DermoSight Dermatoscope FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- Handheld optical skin imaging device FDA UDI
- Model / Reference
- DXH-HW-100 FDA UDI
- Description
- Handheld optical skin imaging device FDA UDI
Identifiers
- Catalog Number
- DXH-HW-100 FDA UDI
- Primary DI / UDI-DI
- 00860013961404 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatoscope, optical
DermoSight Dermatoscope by Deepx Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermatoscope, optical.
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- 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 f263b9f4-1ab8-4df2-9f7e-a063fd460a0d 34 fields · synced May 30, 2026