Identity
- Trade Name
- Firefly FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Digital Endoscopic Camera FDA UDI
- Model / Reference
- DE1270 EUDAMEDFDA UDI
- Description
- Digital Endoscopic Camera FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851289007224 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851289007DE1270NU EUDAMED
- FDA Product Code
- FWL FDA UDI
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
De1270 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 | 0851289007DE1270NU | 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 54501837-68bc-40bd-8f07-35283e67c303 61 fields · synced Jul 9, 2026
- FDA UDI 9443ceae-540f-4de0-94cf-c6994656ff23 33 fields · synced May 30, 2026