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MIRACLEbros 12

by Asahi Intecc Co., Ltd. EUDAMED

Active European Union

Ref AG14M270

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4202096CE01 Date15 May 2026IssuedStatusActive expires 25 Aug 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 4202096TD05 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    15 Nov 2024
    Expires
    13 Aug 2029
    Reason
    Other
  • 4202096CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    15 May 2026
    Expires
    25 Aug 2028
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
AG14M270
Primary DI / UDI-DI
04547327141130
Basic UDI-DI
4547327BGW007NH
EMDN Code
C04010202 Coronary artery therapeutic guidewires, non-hydrophilic
Device Class
Class III
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
JP-MF-000010199
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Asahi Intecc Co., Ltd.

See all devices from Asahi Intecc Co., Ltd. →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

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