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Merit MAK™ D

by Merit Medical Systems, Inc.

Ref MAK501N-PED/DModel Mini Access Kits

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450468340 Basic UDI-DI 00884450468340UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450468340 UDI-DI Date23 Jun 2026ListedStatusListed 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  • Withdrawn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
Merit MAK™
Generic Name
Vascular dilator, single-use
Device Name
Mini Access Kits
Model / Ref / Catalog
Mini Access Kits EUDAMED
MAK501N-PED/D EUDAMED
D GUDID
MAK501N-PED GUDID
Primary DI / UDI-DI
00884450468340
Basic UDI-DI
B-00884450468340
FDA Product Code
DRE
EMDN Code
C010199 Peripheral i.v. catheters and cannulas - other
GMDN Term
Vascular dilator, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1310
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Mini Access Kits
MAK501N-PED/D
GUDID
D
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • Animal Tissues
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

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