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Elefant ASP265

by Coloplast A/S

Part of a family of 10 devices: see the family page

Ref ASP265

Elefant ASP265 is a device classified as Class IIa in the EU and Class II in the US made by Coloplast A/S, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 570893263590085) and listed in FDA GUDID since 5 Apr 2024 (UDI-DI 03600040955086), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number570893263590085 Basic UDI-DI 03600040955086UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040955086 UDI-DI Date5 Apr 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 570893263590085 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 03600040955086 listed 5 Apr 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03600040955086
  2. Registered EUDAMED 570893263590085

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Elefant
Generic name
Surgical irrigation/aspiration cannula, non-illuminating, single-use
Device name
Elefant suction-irrigation device
Model / Ref / Catalog
ASP265
Primary DI / UDI-DI
03600040955086
Basic UDI-DI
570893263590085
FDA product code
FQH
EMDN code
K01020110 Minimally invasive surgery cannulas, single-use
GMDN term
Surgical irrigation/aspiration cannula, non-illuminating, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5475
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5 Millimeter
Length — 350 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Surgical irrigation/aspiration cannula, non-illuminating, single-use

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE.

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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