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Protect Video Laryngoscope System

by Sanitas Healthcare Limited

Ref SKU SAN235PR /PRT11168, SKU SAN248PR /PRT11169Model HY-008 Endoscope Camera, Alcatel 1S

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 Number506078462CAM17G Basic UDI-DI Date8 Aug 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  • Withdrawn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
USB Endoscopic Camera
Smartphone
Model / Reference
HY-008 Endoscope Camera, SKU SAN235PR /PRT11168, Alcatel 1S, SKU SAN248PR /PRT11169
Primary DI / UDI-DI
05060784620288, 15060784620292
Basic UDI-DI
506078462CAM17G, 506078462PHO1BL
EMDN Code
Z12021004 Video laryngoscopes
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000043566

Other devices from Sanitas Healthcare Limited

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