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basixCOMPAK™ 00884450535257

by Merit Medical Systems, Inc.

Ref IN4852/HModel Merit Inflation Devices

basixCOMPAK™ 00884450535257 is a device classified as Class IIa in the EU and Class II in the US made by Merit Medical Systems, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00884450535257) and listed in FDA GUDID since 10 Sep 2021 (UDI-DI 00884450535257), 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-00884450535257 Basic UDI-DI 00884450535257UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450535257 UDI-DI Date10 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450535257 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00884450535257 listed 10 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450535257
  2. Registered EUDAMED B-00884450535257

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  • Withdrawn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
basixCOMPAK™
Generic name
Catheter/overtube balloon inflator, single-use
Device name
Merit Inflation Devices
Model / reference
Merit Inflation Devices EUDAMED
IN4852/H EUDAMED
00884450535257 GUDID
Primary DI / UDI-DI
00884450535257
Basic UDI-DI
B-00884450535257
FDA product code
PTM
EMDN code
Z12030302 Syringe pumps
GMDN term
Catheter/overtube balloon inflator, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1650
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
Merit Inflation Devices
IN4852/H
GUDID
00884450535257
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Catheter/overtube balloon inflator, single-use

Similar devices in this category

Other devices filed under SYRINGE PUMPS.

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)