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Idys™- C 05541307-S

by Clariance, Inc.

Ref 05541307-SModel Idys® C

Idys™- C 05541307-S is a device classified as Class IIb in the EU and Class II in the US made by Clariance, Inc., registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI B-03700780600021) and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 03700780600021), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03700780600021 Basic UDI-DI 03700780600021UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780600021 UDI-DI Date23 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03700780600021 registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 03700780600021 listed 23 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700780600021
  2. Registered EUDAMED B-03700780600021

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  • Withdrawn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
Cage Cervicale (W14 D13 H07 Mm) EUDAMED
Idys™- C GUDID
Generic name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
05541307-S, Idys® C
Primary DI / UDI-DI
03700780600021
Basic UDI-DI
B-03700780600021
FDA product code
ODP
EMDN code
P09070101 Spinal cages
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Height — 7 Millimeter
Depth — 13 Millimeter
Width — 14 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Polymeric spinal interbody fusion cage

Similar devices in this category

Other devices filed under SPINAL CAGES.

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)