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IBS Angel

by Biotyx Medical (Shenzhen) Co., Ltd. 46 variants

Ref LT-ANGEL-22528Model Vascular Stent

Active European Union

CE MDR

Valid until

1 Feb 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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 Number2245935CE01 Date18 Aug 2023IssuedStatusActive expires 1 Feb 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2245935CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    18 Aug 2023
    Expires
    1 Feb 2028
    Reason
    Other
  • 2245935TD01 Active Amended

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    18 Aug 2023
    Expires
    1 Feb 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
IBS Angel Iron Bioresorbable Scaffold System
Model / Reference
Vascular Stent, LT-ANGEL-22528
Primary DI / UDI-DI
06972501940069
Basic UDI-DI
69725019454101YJ
EMDN Code
P0704020299 Peripheral vascular stents - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011475
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Biotyx Medical (Shenzhen) Co., Ltd.

  • IBS Angel

    Class III

  • IBS Angel

    Class III

  • IBS Angel

    Class III

  • IBS Angel

    Class III

  • IBS Angel

    Class III

  • IBS Angel

    Class III

See all devices from Biotyx Medical (Shenzhen) Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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