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IlluminOss CT-0196

by IlluminOss Medical

Ref CT-0196

IlluminOss CT-0196 is a device classified as Class I in the EU and Class II in the US made by IlluminOss Medical, registered in EUDAMED on 8 May 2026 (Basic UDI-DI ++M986SEPARATORSST), granted FDA De Novo DEN160062 on 19 Dec 2017 and listed in FDA GUDID since 28 Aug 2020 (UDI-DI M986CT01960), active as of 8 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR De Novo

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

De Novo DEN160062

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++M986SEPARATORSST Basic UDI-DI M986CT01960UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberM986CT01960 UDI-DI Date28 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG GUDID from GUDID De Novo granted · Direct NumberDEN160062 Date19 Dec 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++M986SEPARATORSST registered 8 May 2026 Active
  • FDA De Novo DEN160062 decided 19 Dec 2017 Active
  • FDA GUDID UDI-DI M986CT01960 listed 28 Aug 2020 Listed

Timeline

3 dated events

  1. Granted FDA De Novo DEN160062
  2. Listed FDA GUDID M986CT01960
  3. Registered EUDAMED ++M986SEPARATORSST

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA De Novo Active

Specification

EUDAMED · GUDID

Trade name
IlluminOss Reusable Instruments EUDAMED
IlluminOss GUDID
Generic name
Orthopaedic bone pin, non-bioabsorbable
Device name
Class 1r & 1m Reusable Surgical Instruments
Model / Ref / Catalog
CT-0196
Primary DI / UDI-DI
M986CT01960
Basic UDI-DI
++M986SEPARATORSST
Direct marketing DI
+M986CT01960E
De Novo Number
FDA product code
QAD, LXH
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3023, 888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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.

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (DEN160062)

and 8 more cleared under DEN160062

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from IlluminOss Medical

See all devices from IlluminOss Medical →

Properties

  • Sterilise before use
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)