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Slit Lamp Microscope

by Shanghai Mediworks Precision Instruments Co., Ltd. 19 variants

Part of a family of 20 devices: see the family page

Ref S260

Slit Lamp Microscope (S260) is an ophthalmic examination slit lamp (EU MDR Class I; FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Shanghai Mediworks Precision Instruments Co., Ltd., registered in EUDAMED on 21 Apr 2023 (Basic UDI-DI 69450875SlitLamp2P), cleared under FDA 510(k) K152429 on 11 May 2016 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 06945087526019), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152429↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69450875SlitLamp2P Basic UDI-DI 06945087526019UDI-DIDate21 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945087526019 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK152429 Date11 May 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69450875SlitLamp2P registered 21 Apr 2023 Active
  • FDA 510(k) K152429 decided 11 May 2016 Active
  • FDA GUDID UDI-DI 06945087526019 listed 1 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152429
  2. Listed FDA GUDID 06945087526019
  3. Registered EUDAMED 69450875SlitLamp2P

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  • Withdrawn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
Slit Lamp Microscope EUDAMED
MediWorks GUDID
Generic name
Ophthalmic examination slit lamp
Device name
Slit Lamp Microscopes
Model / reference
S260
Primary DI / UDI-DI
06945087526019
Basic UDI-DI
69450875SlitLamp2P
Direct marketing DI
06945087526019
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
Ireland
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
CN-MF-000004251
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)