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Ablation Depth Checker

by SMT Swiss Microtechnology AG

Ref 610.800.012Model AQUARIUZ Accessories

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764016775ABLACC95 Basic UDI-DI 07640167751419UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
AQUARIUZ Corneal Ablation Laser Accessories
Model / Reference
AQUARIUZ Accessories, 610.800.012
Primary DI / UDI-DI
07640167751419
Basic UDI-DI
764016775ABLACC95
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000025016
Authorised representative
Ziemer Ophthalmology (DE) GmbH DE-AR-000005638

Other devices from SMT Swiss Microtechnology AG

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