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CORIS® Device

by Nanosonics Limited

Ref N05515

CORIS® Device (N05515) is a device classified as Class I in the EU and Class II in the US made by Nanosonics Limited, registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI 93508550ERCO-B-ECC-ZG) and listed in FDA GUDID since 20 May 2026 (UDI-DI 09350855000993), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09350855000993 UDI-DI Date20 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number93508550ERCO-B-ECC-ZG Basic UDI-DI 09350855000993UDI-DIDate16 Apr 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 93508550ERCO-B-ECC-ZG registered 16 Apr 2026 Active
  • FDA GUDID UDI-DI 09350855000993 listed 20 May 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 93508550ERCO-B-ECC-ZG
  2. Listed FDA GUDID 09350855000993

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  • Withdrawn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
CORIS Device Body
Generic name
Endoscope flushing/rinsing sink system
Device name
CORIS® Device
Model / reference
N05515
Primary DI / UDI-DI
09350855000993
Basic UDI-DI
93508550ERCO-B-ECC-ZG
Direct marketing DI
09350855000764
FDA product code
SEW
EMDN code
Z12011311 Endoscope washers
GMDN term
Endoscope flushing/rinsing sink system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6994
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
AU-MF-000014803
Authorised representative
Nanosonics Europe GmbH DE-AR-000005870

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Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)