IlluminOss CT-0301: CE/MDR Class I, IlluminOss Medical

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number++M986SEPARATORSST Basic UDI-DI M986CT03010UDI-DI	Date8 May 2026Registered	StatusActive
United States	GUDID listing GUDID	NumberM986CT03010 UDI-DI	Date28 Aug 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA De NovoDENG GUDID from GUDID De Novo granted · Direct	NumberDEN160062	Date19 Dec 2017Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI ++M986SEPARATORSST — open Devices and search for it
FDA De Novo database De Novo number DEN160062

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 M986CT03010 listed 28 Aug 2020 Listed

Timeline

3 dated events

19 Dec 2017 Granted FDA De Novo DEN160062
28 Aug 2020 Listed FDA GUDID M986CT03010
8 May 2026 Registered EUDAMED ++M986SEPARATORSST

Coverage

2 jurisdictions

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Withdrawn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-0301

Primary DI / UDI-DI: M986CT03010
Basic UDI-DI: ++M986SEPARATORSST
Direct marketing DI: +M986CT030102
De Novo Number: DEN160062
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

Field	EUDAMED	GUDID
Device class	EUDAMED Class I	GUDID Class II
Implantable	EUDAMED 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.