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Zeos

by Santa Barbara Imaging Systems, Inc. 7 variants

Ref 84-10-5301

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0812231038X-10-XXXXWW Basic UDI-DI 00812231034590UDI-DIDate22 Oct 2024RegisteredStatusActive

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  • Withdrawn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
4K HDR Camera System
Model / Reference
84-10-5301
Primary DI / UDI-DI
00812231034590
Basic UDI-DI
0812231038X-10-XXXXWW
Direct Marketing DI
00812231034590
EMDN Code
Z12020405 Surgical cameras
Device Class
Class I
EU 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

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