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Microclear

by Suzhou Microclear Medical Instruments Co., Ltd 4 variants

Ref HSL-01Model HSL,HSL-01,HSL-02,HSL-03

Microclear (HSL-01) is an ophthalmic examination slit lamp (EU MDR Class I; FDA Class II; FDA product code PUE, Biomicroscope, Slit-Lamp, Ac-Powered, Exempt) made by Suzhou Microclear Medical Instruments Co., Ltd., registered in EUDAMED on 4 Jan 2022 (Basic UDI-DI 697099016HSLUL) and listed in FDA GUDID since 27 Jan 2021 (UDI-DI 06970990160074), 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 Number697099016HSLUL Basic UDI-DI 06970990160074UDI-DIDate4 Jan 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06970990160074 UDI-DI Date27 Jan 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697099016HSLUL registered 4 Jan 2022 Active
  • FDA GUDID UDI-DI 06970990160074 listed 27 Jan 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06970990160074
  2. Registered EUDAMED 697099016HSLUL

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  • Withdrawn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

Generic name
Ophthalmic examination slit lamp
Device name
Digital Hand-held Slit Lamp
Model / reference
HSL, HSL-01, HSL-02, HSL-03
Primary DI / UDI-DI
06970990160074
Basic UDI-DI
697099016HSLUL
Direct marketing DI
06970990160074
FDA product code
PUE
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
Netherlands
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-000014411
Authorised representative
Wellkang Ltd XI-AR-000001836

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Other devices filed under SLIT LAMPS.

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Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)