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Medallion® 00884450025796

by Merit Medical Systems, Inc.

Ref K01-60086Model Medallion®

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450025796 Basic UDI-DI 00884450025796UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450025796 UDI-DI Date17 Sep 2018ListedStatusListed 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Medallion®
Generic Name
General-purpose syringe, single-use
Device Name
Syringes
Model / Ref / Catalog
Medallion®, K01-60086, 00884450025796
Primary DI / UDI-DI
00884450025796
Basic UDI-DI
B-00884450025796
FDA Product Code
FMF
EMDN Code
A020101 Loss-of-resistance syringes
GMDN Term
General-purpose syringe, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Medallion®
K01-60086
GUDID
00884450025796
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: General-purpose syringe, single-use

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • Animal Tissues
  • Measuring Function
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No