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ASAHI PTCA Guide Wire ASAHI SION 190cm Pre-shape

by Asahi Intecc Co., Ltd.

Ref AHW14R101P

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

25 Aug 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4202096CE01 Date15 May 2026IssuedStatusActive expires 25 Aug 2028
European UnionCE/MDD EUDAMED NumberB-04547327132961 Basic UDI-DI 04547327132961UDI-DIDate22 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04547327132961 UDI-DI Date7 Dec 2019ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 4202096TD09 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    26 Sep 2025
    Expires
    26 Sep 2030
  • 4202096CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 May 2026
    Expires
    25 Aug 2028
    Reason
    Add device or group

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ASAHI PTCA Guide Wire ASAHI SION 190cm Pre-shape EUDAMED
Sion EUDAMED
Asahi Sion GUDID
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Device Name
ASAHI PTCA Guide Wire ASAHI SION and SUOH 03
PCI Guide Wire SION PCI Guide Wire SION blue PCI Guide Wire SION black PCI Guide Wire SION blue ES PCI Guide Wire SUOH 03
Model / Reference
AHW14R101P
Primary DI / UDI-DI
04547327132961
Basic UDI-DI
B-04547327132961, 4547327BGW011N8
FDA Product Code
DQX
EMDN Code
C04030201, C04010201
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1330
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Size
Length — 190 Centimeter
Outer Diameter — 0.014 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

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
  • Single Use
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No