DE500
Ref DE500
DE500 is a Class I device made by Firefly Global, registered in EUDAMED on 29 Dec 2025 (Basic UDI-DI 0851289007DE500Q9) and listed in FDA GUDID since 10 Sep 2018 (UDI-DI 00851289007064), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0851289007DE500Q9 00851289007064 | Date29 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00851289007064 | Date10 Sep 2018 | StatusListed |
Official records
- EUDAMED public site 0851289007DE500Q9
- AccessGUDID record 00851289007064
Across registries
- EUDAMED Basic UDI-DI 0851289007DE500Q9 registered 29 Dec 2025 Active
- FDA GUDID UDI-DI 00851289007064 listed 10 Sep 2018 Listed
Timeline
- Listed FDA GUDID 00851289007064
- Registered EUDAMED 0851289007DE500Q9
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Firefly
- Generic name
- Otoscope, direct
- Model / reference
- DE500
- Primary DI / UDI-DI
- 00851289007064
- Basic UDI-DI
- 0851289007DE500Q9
- FDA product code
- ERA
- EMDN code
- Z12149006 Direct outpatient otoscopes
- GMDN term
- Otoscope, direct
- Device class
- Class I
- Regulation number
- 874.4770
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000020015
- Authorised representative
- MDSS GmbH DE-AR-000005430
Similar devices in this category
Other devices filed under DIRECT OUTPATIENT OTOSCOPES.