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Klarity SGRT System

by Klarity Medical & Equipment（GZ） Co., Ltd. 2 variants

Ref ARSG-E3AModel ARSG-E1A, ARSG-E3A

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K241937↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number692082412500CT Basic UDI-DI 06920824156100UDI-DIDate23 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK241937 Date18 Mar 2025IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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)

Device Name
Klarity SGRT System
Model / Reference
ARSG-E1A, ARSG-E3A
Primary DI / UDI-DI
06920824156100
Basic UDI-DI
692082412500CT
EMDN Code
Z11030599 Radiology instruments - other
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000002229
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Klarity Medical & Equipment（GZ） Co., Ltd.

See all devices from Klarity Medical & Equipment（GZ） Co., Ltd. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No