Identity
- Trade Name
- MoleScope II FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magnification and cross-polarized light. It is a reusable, non-invasive device for imaging and documentation only. FDA UDI
- Model / Reference
- 850147000018 FDA UDI
- Description
- MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magnification and cross-polarized light. It is a reusable, non-invasive device for imaging and documentation only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850147000018 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Dermatoscope, optical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatoscope, optical
MoleScope II by MetaOptima Technology Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- MetaOptima Technology Inc
Sources (1)
- FDA UDI ee48f083-85db-42e4-8667-bbed03a7ab79 34 fields · synced Jun 8, 2026