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Miser™ 00884450099896

by Merit Medical Systems, Inc.

Ref MISER4/BModel Miser™

Miser™ 00884450099896 is a device classified as Class I in the EU and Class II in the US made by Merit Medical Systems, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-00884450099896) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00884450099896), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450099896 Basic UDI-DI 00884450099896UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450099896 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450099896 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00884450099896 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450099896
  2. Registered EUDAMED B-00884450099896

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  • Withdrawn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
Miser™
Generic name
Basic intravenous administration set, noninvasive
Device name
Contrast Management System
Model / reference
Miser™ EUDAMED
MISER4/B EUDAMED
00884450099896 GUDID
Primary DI / UDI-DI
00884450099896
Basic UDI-DI
B-00884450099896
FDA product code
FPA
EMDN code
A030499 Administration kits - other
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Miser™
MISER4/B
GUDID
00884450099896
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ADMINISTRATION KITS - OTHER.

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Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)