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Sereny™ Hemostasis Introducer

by APT Medical Inc. 224 variants

Ref 152B0611PA25TModel 4F, 5F, 6F, 7F, 8F

Active European Union

CE MDR

Valid until

6 Jun 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN23/00002940 Date10 Jul 2026IssuedStatusActive expires 6 Jun 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN23/00002940 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    10 Jul 2026
    Expires
    6 Jun 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
4F, 5F, 6F, 7F, 8F, 152B0611PA25T
Primary DI / UDI-DI
06942075353435
Basic UDI-DI
69318961INS152SE
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
EU market of registration
Germany

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
  • CMR Substance
  • Endocrine Disruptor

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No