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Inject8™ 00884450025406

by Merit Medical Systems, Inc.

Ref CCSW881/BModel CCS

Inject8™ 00884450025406 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 30 Oct 2026 (Basic UDI-DI B-00884450025406) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00884450025406), 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-00884450025406 Basic UDI-DI 00884450025406UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450025406 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450025406 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00884450025406 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450025406
  2. Registered EUDAMED B-00884450025406

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  • Withdrawn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
Inject8™
Generic name
Angiographic syringe
Device name
Syringes
Model / reference
CCS EUDAMED
CCSW881/B EUDAMED
00884450025406 GUDID
Primary DI / UDI-DI
00884450025406
Basic UDI-DI
B-00884450025406
FDA product code
DXT
EMDN code
A020101 Loss-of-resistance syringes
GMDN term
Angiographic syringe
Device class
Class I 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
CCS
CCSW881/B
GUDID
00884450025406
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.

Related devices

Category: General-purpose syringe, single-useAngiographic syringe

Similar devices in this category

Other devices filed under LOSS-OF-RESISTANCE SYRINGES.

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
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)