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DE508

by Firefly Global

Ref DE508

DE508 is a Class I device made by Firefly Global, registered in EUDAMED on 2 Jan 2026 (Basic UDI-DI 0851289007DE508QR) and listed in FDA GUDID since 24 Oct 2024 (UDI-DI 00851289007330), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851289007DE508QR Basic UDI-DI 00851289007330UDI-DIDate2 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00851289007330 UDI-DI Date24 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0851289007DE508QR registered 2 Jan 2026 Active
  • FDA GUDID UDI-DI 00851289007330 listed 24 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00851289007330
  2. Registered EUDAMED 0851289007DE508QR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Firefly
Generic name
Otoscope, direct
Model / reference
DE508
Primary DI / UDI-DI
00851289007330
Basic UDI-DI
0851289007DE508QR
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.

Other devices from Firefly Global

See all devices from Firefly Global →

Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)