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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 S280CModel S260

Slit Lamp Microscope (S280C) 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 06945087528037), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152429

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69450875SlitLamp2P Basic UDI-DI 06945087528037UDI-DIDate21 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945087528037 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID 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 06945087528037 listed 1 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152429
  2. Listed FDA GUDID 06945087528037
  3. Registered EUDAMED 69450875SlitLamp2P

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  • Withdrawn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
Slit Lamp Microscope EUDAMED
MediWorks GUDID
Generic name
Ophthalmic examination slit lamp
Model / reference
S260, S280C
Primary DI / UDI-DI
06945087528037
Basic UDI-DI
69450875SlitLamp2P
Direct marketing DI
06945087528037
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
Austria
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

Similar devices in this category

Other devices filed under SLIT LAMPS.

Other devices from Shanghai Mediworks Precision Instruments Co., Ltd.

See all devices from Shanghai Mediworks Precision Instruments Co., Ltd. →

Properties

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