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Ophthalmic Ultrasound Scanner

by Appasamy Associates Private Limited 4 variants

Ref Marvel B-scan

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 Number89043437BSCANPR Basic UDI-DI 08904343742073UDI-DIDate3 Mar 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  • Withdrawn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
Ophthalmic Ultrasound Scanner
Model / Reference
Marvel B-scan
Primary DI / UDI-DI
08904343742073
Basic UDI-DI
89043437BSCANPR
EMDN Code
Z11040199 Ultrasound scanners - other
Device Class
Class IIa
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
IN-MF-000013149
Authorised representative
Amstermed B.V. NL-AR-000001971

Other devices from Appasamy Associates Private Limited

See all devices from Appasamy Associates Private Limited →

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