Identity
- Trade Name
- Firefly FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- Compact handheld light source (battery operated) FDA UDI
- Model / Reference
- ES201 EUDAMEDFDA UDI
- Description
- Compact handheld light source (battery operated) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851289007002 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851289007ES201T9 EUDAMED
- Direct Marketing DI
- 00851289007002 EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Endoscopic light source unit, battery-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Es201 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 | 0851289007ES201T9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Firefly Global
- EUDAMED SRN
- US-MF-000020015
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 061c3bb0-f130-4fd7-b88a-8c0cf099de14 61 fields · synced Jun 19, 2026
- FDA UDI d797e625-4ed9-4880-8c3c-4c16b8fd6379 33 fields · synced May 30, 2026