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Micra™ Introducer MI2355A

by Medtronic, Inc.

Ref MI2355A

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

CE AIMDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00643169359895 Basic UDI-DI 00643169359895UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169359895 UDI-DI Date7 Aug 2016ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Micra™ EUDAMED
Micra™ Introducer GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Device Name
Micra Introducer
Model / Reference
MI2355A
Primary DI / UDI-DI
00643169359895 EUDAMED
00643169359888 GUDID
Basic UDI-DI
B-00643169359895
510(k) Number
FDA Product Code
DYB
EMDN Code
J01900180 Permanent cardiac leads - accessories
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class AIMDD EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00643169359895
GUDID
00643169359888
Device ClassEUDAMED
Class AIMDD
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

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