Cemex System 80g 1500/S: CE/MDR Class IIb, Tecres

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number80314970160NM Basic UDI-DI 28031497000217UDI-DI	Date24 Sep 2026Registered	StatusActive
United States	GUDID listing GUDID	Number28031497000217 UDI-DI	Date7 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK000943	Date8 Feb 2001Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 80314970160NM — open Devices and search for it
AccessGUDID record UDI-DI 28031497000217
FDA 510(k) database 510(k) number K000943

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 80314970160NM registered 24 Sep 2026 Active
FDA 510(k) K000943 decided 8 Feb 2001 Active
FDA GUDID UDI-DI 28031497000217 listed 7 Oct 2015 Listed

Certificates

1 certificate · EUDAMED

MDR 773681 Active Amended

Technical documentation EU MDR

Certifier

BSI Group The Netherlands B.V. 2797

Issued
19 Feb 2026

Expires
4 Nov 2030

Reason
Other

Timeline

3 dated events

8 Feb 2001 Cleared FDA 510(k) K000943
7 Oct 2015 Listed FDA GUDID 28031497000217
24 Sep 2026 Registered EUDAMED 80314970160NM

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Cemex System 80g
Generic name: Orthopaedic cement preparation/delivery kit
Model / reference: 1500/S

Primary DI / UDI-DI: 28031497000217
Basic UDI-DI: 80314970160NM
510(k) Number: K000943
FDA product code: LOD
EMDN code: P099002 Orthopaedic cement preparation and application devices and kits
GMDN term: Orthopaedic cement preparation/delivery kit

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 888.3027
EU registration type: Standard device
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIb	GUDID Class II
Implantable	EUDAMED Yes	GUDID No

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.