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FL800 Ult

by Leica Microsystems (Schweiz) AG

Ref 10449023Model FL800 ULT

FL800 Ult (10449023) is a surgical microscope fluorescent angiography system (EU MDR Class IIa; FDA Class II; FDA product code IZI, System, x-ray, angiographic) made by Leica Microsystems (Schweiz) AG, registered in EUDAMED on 10 Nov 2025 (Basic UDI-DI 76300035FL8007W), cleared under FDA 510(k) K080612 on 9 May 2008 and listed in FDA GUDID since 20 Nov 2018 (UDI-DI 07630003593587), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080612↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300035FL8007W Basic UDI-DI 07630003593587UDI-DIDate10 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630003593587 UDI-DI Date20 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK080612 Date9 May 2008IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76300035FL8007W registered 10 Nov 2025 Active
  • FDA 510(k) K080612 decided 9 May 2008 Active
  • FDA GUDID UDI-DI 07630003593587 listed 20 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K080612
  2. Listed FDA GUDID 07630003593587
  3. Registered EUDAMED 76300035FL8007W

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
FL800 Ult EUDAMED
Leica FL800 ULT GUDID
Generic name
Surgical microscope fluorescent angiography system
Model / reference
FL800 ULT EUDAMED
10449023 EUDAMED
000000000010449023 GUDID
Primary DI / UDI-DI
07630003593587
Basic UDI-DI
76300035FL8007W
FDA product code
IZI
EMDN code
Z12011199 Instruments for operative microscopy – other
GMDN term
Surgical microscope fluorescent angiography system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1600
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FL800 ULT
10449023
GUDID
000000000010449023
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
CH-MF-000021185
Authorised representative
Leica Microsystems CMS GmbH DE-AR-000021052

Similar devices in this category

Other devices filed under INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER.

Other devices from Leica Microsystems (Schweiz) AG

See all devices from Leica Microsystems (Schweiz) AG →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)