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Quikclot IPN928786

by Teleflex Incorporated

Ref 188Model IPN928786

Quikclot IPN928786 (188) is a device classified as Class III (EU), Unclassified (US) made by Teleflex Incorporated, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-10841495150248) and listed in FDA GUDID since 8 Jan 2024 (UDI-DI 10841495150248), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10841495150248 Basic UDI-DI 10841495150248UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841495150248 UDI-DI Date8 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10841495150248 registered 22 Sep 2026 Active
  • FDA GUDID UDI-DI 10841495150248 listed 8 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10841495150248
  2. Registered EUDAMED B-10841495150248

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  • Withdrawn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
QuikClot Interventional Pre-Slit w/ Tegaderm EUDAMED
Quikclot GUDID
Generic name
Chitosan haemostatic agent, professional, non-bioabsorbable
Device name
Qc Interventional,preslit,multi-Lan
Model / Ref / Catalog
IPN928786, 188
Primary DI / UDI-DI
10841495150248
Basic UDI-DI
B-10841495150248
FDA product code
FRO
EMDN code
M040504 Inorganic haemostatic devices
GMDN term
Chitosan haemostatic agent, professional, non-bioabsorbable
Device class
Class III EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
U

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

Related devices

Category: Chitosan haemostatic agent, professional, non-bioabsorbable

Similar devices in this category

Other devices filed under INORGANIC HAEMOSTATIC DEVICES.

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Properties

  • Supplied sterile
  • Single use
  • Incorporates a medicinal substance
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)