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Sl 800

by Carl Zeiss Meditec AG

Ref 2268-355Model SL 800

Sl 800 (2268-355) is a device classified as Class I in the EU and Class II in the US made by Carl Zeiss Meditec AG, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI 4049471_SL0002_YY), cleared under FDA 510(k) K162684 on 31 May 2017 and listed in FDA GUDID since 13 Jan 2026 (UDI-DI 04049471097153), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162684

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049471_SL0002_YY Basic UDI-DI 04049471097153UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049471097153 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162684 Date31 May 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4049471_SL0002_YY registered 29 Jul 2026 Active
  • FDA 510(k) K162684 decided 31 May 2017 Active
  • FDA GUDID UDI-DI 04049471097153 listed 13 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162684
  2. Listed FDA GUDID 04049471097153
  3. Registered EUDAMED 4049471_SL0002_YY

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Sl 800 EUDAMED
Sl 220 GUDID
Generic name
Ophthalmic examination slit lamp
Device name
Slit Lamps
Model / reference
SL 800, 2268-355
Primary DI / UDI-DI
04049471097153
Basic UDI-DI
4049471_SL0002_YY
Direct marketing DI
04049471097153
510(k) Number
FDA product code
HJO
EMDN code
Z12120108 Slit lamps
GMDN term
Ophthalmic examination slit lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1850
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
DE-MF-000007732

Similar devices in this category

Other devices filed under SLIT LAMPS.

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Properties

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