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ES201

by Firefly Global

Ref ES201

ES201 is a device classified as Class I in the EU and Class II in the US made by Firefly Global, registered in EUDAMED on 2 Jan 2026 (Basic UDI-DI 0851289007ES201T9) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851289007002), 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 Number0851289007ES201T9 Basic UDI-DI 00851289007002UDI-DIDate2 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00851289007002 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0851289007ES201T9 registered 2 Jan 2026 Active
  • FDA GUDID UDI-DI 00851289007002 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00851289007002
  2. Registered EUDAMED 0851289007ES201T9

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  • Withdrawn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
Endoscopic light source unit, battery-powered
Model / reference
ES201
Primary DI / UDI-DI
00851289007002
Basic UDI-DI
0851289007ES201T9
Direct marketing DI
00851289007002
FDA product code
NTN
EMDN code
Z129004 Light sources
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000020015
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under LIGHT SOURCES.

Other devices from Firefly Global

See all devices from Firefly Global →

Properties

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