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Radilock™

by APT Medical Inc. 6 variants

Ref 176I26Model Type I

Active European Union

CE MDR

Valid until

6 Jun 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN23/00002940 Date3 Sep 2026IssuedStatusActive expires 6 Jun 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CN23/00002940 Active Supplemented Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    10 Jul 2026
    Expires
    6 Jun 2028
    Reason
    Add device or group
  • CN23/00002940 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    3 Sep 2026
    Expires
    6 Jun 2028
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Radilock™ Radial Compression Device
Model / Reference
Type I, 176I26
Primary DI / UDI-DI
06931896185707
Basic UDI-DI
69318961ZXD011768C
EMDN Code
V9003 Tourniquets
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000009046
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from APT Medical Inc.

See all devices from APT Medical Inc. →

Properties

  • Sterile

Other properties (12)

  • 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