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Ophthalmic Optical Coherence Tomography Systems

by TowardPi (Shanghai) Medical Technology Ltd. EUDAMED

Active European Union

Ref BM-400K UltraModel BM-400K Ultra, BM-400K MAX, BM-400K NF, BM-400K, BM Lite

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697599466BM400KR2 Basic UDI-DIDate10 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
BM-400K Ultra, BM-400K MAX, BM-400K NF, BM-400K, BM Lite
Primary DI / UDI-DI
06975994660247
Basic UDI-DI
697599466BM400KR2
Direct Marketing DI
06975994660247
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000033952
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from TowardPi (Shanghai) Medical Technology Ltd.

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Properties

Show properties
  • 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