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Gladius MG14

by Asahi Intecc Co., Ltd. 2 variants

Part of a family of 18 devices: see the family page

Ref AP14R223P

Gladius MG14 (AP14R223P) is a Class III device made by Asahi Intecc Co., Ltd., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 4547327AGW020MU), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4547327AGW020MU Basic UDI-DI 04547327144995UDI-DIDate28 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
PCI Guide Wire Gladius EX14, Gladius MG Series
Model / reference
AP14R223P
Primary DI / UDI-DI
04547327144995
Basic UDI-DI
4547327AGW020MU
EMDN code
C04010201 Coronary artery therapeutic guidewires, hydrophilic
Device class
Class III
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

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

Similar devices in this category

Other devices filed under CORONARY ARTERY GUIDEWIRES.

Other devices from Asahi Intecc Co., Ltd.

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

Properties

  • Supplied sterile
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
Other properties (12, all answered No)