Identity
- Trade Name
- FotoFinder leviacam FDA UDI
- Generic Name
- Dermatoscope, digital FDA UDI
- Device Name
- FotoFinder leviacam EUDAMEDFotoFinder leviacam is a video dermatoscope to take images of intact skin, scalp, hair and nail with high magnification and cross-polarized light. It is a non-invasive device for imaging and documentation only. FDA UDI
- Model / Reference
- FFS720160 EUDAMEDV1 FDA UDI
- Description
- FotoFinder leviacam is a video dermatoscope to take images of intact skin, scalp, hair and nail with high magnification and cross-polarized light. It is a non-invasive device for imaging and documentation only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260158450089 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015845LC001W5 EUDAMED
- Direct Marketing DI
- 04260158450089 EUDAMED
- FDA Product Code
- IBJ FDA UDI
- EMDN Code
- Z12040118 VIDEO DERMATOSCOPES EUDAMED
- GMDN Term
- Dermatoscope, digital FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.3600 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
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, digital
FotoFinder leviacam by FotoFinder Systems GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dermatoscope, digital.
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- MEICET — Shanghai May Skin Information Technology Co., Ltd. · Class II
- DIGITAL MEDICAL SCOPE — Nidek, Inc. · Class I
- DIGITAL MEDICAL SCOPE — Nidek, Inc. · Class I
- MEICET — Shanghai May Skin Information Technology Co., Ltd. · Class II
- MEICET — Shanghai May Skin Information Technology Co., Ltd. · Class II
- DIGITAL MEDICAL SCOPE — Nidek, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FotoFinder Systems GmbH
Sources (2)
- FDA UDI 87ab27f1-e9c9-47a7-94b7-e36b56104159 33 fields · synced Jul 16, 2026
- EUDAMED a773ea98-8d54-4bc3-84ab-4c79a49ab0fc 61 fields · synced Jul 16, 2026