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Zeos

by Santa Barbara Imaging Systems, Inc. United States EUDAMED

Ref 84-10-5330

EMDN Z12020405

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0812231038X-10-XXXXWW Basic UDI-DIDate22 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
4K HDR Camera System
Model / Reference
84-10-5330
Primary DI / UDI-DI
00812231034651
Basic UDI-DI
0812231038X-10-XXXXWW
Direct Marketing DI
00812231034651
EMDN Code
Z12020405 Surgical cameras
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007262
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Other devices from Santa Barbara Imaging Systems, Inc.

See all devices from Santa Barbara Imaging Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 7c5845f4-ed96-4dc1-8bed-0a1a7da6d8e7 61 fields · synced 22 Oct 2026