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Core Dynamics

by Conmed Corporation EUDAMEDGUDID

Active European Union

Ref CD8302

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10653405046233 Basic UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405046233 UDI-DIDate24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Surgical irrigation/aspiration tubing set
Device Name
Non-orthopedic, Non-active, Instrument, Suction/Irrigation, Handpiece and Tubing, Core Trumpet
Model / Ref / Catalog
CD8302
Primary DI / UDI-DI
10653405046233
Basic UDI-DI
B-10653405046233
FDA Product Code
GBW
EMDN Code
A03040299 Irrigation kits, single-use - other
GMDN Term
Surgical irrigation/aspiration tubing set
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4200
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

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