Identity
- Trade Name
- Firefly FDA UDI
- Generic Name
- Dermatoscope, digital FDA UDI
- Device Name
- Digital Dermatoscope FDA UDI
- Model / Reference
- DE300 EUDAMEDFDA UDI
- Description
- Digital Dermatoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851289007071 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851289007DE300PX EUDAMED
- FDA Product Code
- KYT FDA UDI
- EMDN Code
- Z12040108 DERMATOSCOPES EUDAMED
- GMDN Term
- Dermatoscope, digital FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6350 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
No
FDA UDI
De300 by Firefly Global — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851289007DE300PX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Firefly Global
- EUDAMED SRN
- US-MF-000020015
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 873e7366-7058-4885-901b-ad8d954d461d 61 fields · synced Jul 15, 2026
- FDA UDI 13d580f1-fd02-4089-9f7e-e201afa143f4 33 fields · synced May 30, 2026