Identity
- Trade Name
- Firefly FDA UDI
- Generic Name
- Multi-purpose digital medical camera lens, extraocular FDA UDI
- Device Name
- Digital Iris Scope FDA UDI
- Model / Reference
- DE400 EUDAMEDFDA UDI
- Description
- Digital Iris Scope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851289007088 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851289007DE400Q4 EUDAMED
- FDA Product Code
- HRB FDA UDI
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Multi-purpose digital medical camera lens, extraocular FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 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
De400 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 | 0851289007DE400Q4 | 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 59b3636b-acb9-4912-9f72-718403d9becc 61 fields · synced Jun 17, 2026
- FDA UDI 336a9faf-cab0-44fc-9657-a713aef21e8d 33 fields · synced May 30, 2026