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Optical Biometer

by Shanghai Mediworks Precision Instruments Co., Ltd. United States EUDAMED

Ref AL551Model AL550

EMDN Z12120102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69450875OpticalBiometerFE Basic UDI-DIDate3 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
AL550, AL551
Primary DI / UDI-DI
06945087555101
Basic UDI-DI
69450875OpticalBiometerFE
Direct Marketing DI
06945087555101
EMDN Code
Z12120102 Computerised optical biometers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000004251
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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

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

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED be78b727-8d5d-4e32-a356-8cd1a2667a98 61 fields · synced 23 Oct 2026