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Merit Medical®

by Merit Medical Systems, Inc. 69 variants

Ref K15-00319A

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0884450BUDI659QN Basic UDI-DI 00884450486603UDI-DIDate9 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
K15 & K21 Vascular catheter introduction kit
Model / Reference
K15-00319A
Primary DI / UDI-DI
00884450486603
Basic UDI-DI
0884450BUDI659QN
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class IIa
Medical Purpose
To facilitate the placement of catheters through the skin into a vein or artery.

Manufacturer details

EUDAMED SRN
US-PR-000008345

Other devices from Merit Medical Systems, Inc.

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Properties

  • Sterile