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Elepy Technology- RGP Contact Lens Cleaner

by Suzhou 3N Biological Technology Co., Ltd

Ref /Model TN086

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69389142TN086UU Basic UDI-DI 06938914200862UDI-DIDate14 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Elepy Technology- RGP Contact Lens Cleaner
Model / Reference
TN086, /
Primary DI / UDI-DI
06938914200862
Basic UDI-DI
69389142TN086UU
Direct Marketing DI
06938914200862
EMDN Code
Z12011380 Cleaning, disinfection and sterilisation instruments - hardware accessories
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000050449
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Suzhou 3N Biological Technology Co., Ltd

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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