Skip to content

Apex C7120

by Conmed Corporation

Ref C7120

Apex C7120 is a device classified as Class IIa in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-10845854012178) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10845854012178), 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-10845854012178 Basic UDI-DI 10845854012178UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854012178 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10845854012178 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 10845854012178 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10845854012178
  2. Registered EUDAMED B-10845854012178

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  • Withdrawn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
Apex
Generic name
Surgical irrigation tubing set, single-use
Device name
Fluid Delivery System
Model / Ref / Catalog
C7120
Primary DI / UDI-DI
10845854012178
Basic UDI-DI
B-10845854012178
FDA product code
HRX
EMDN code
A03040299 Irrigation kits, single-use - other
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.1100
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10845854012178: EUDAMED states No, FDA GUDID states Yes.

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.

Similar devices in this category

Other devices filed under IRRIGATION KITS, SINGLE-USE - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)