Tempus Pro 01-2501: CE/MDR Class I

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number506047244BM731V8 Basic UDI-DI 05060472440419UDI-DI	Date19 May 2026Registered	StatusActive
United States	GUDID listing GUDID	Number05060472440419 UDI-DI	Date4 Oct 2016Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 506047244BM731V8 — open Devices and search for it
AccessGUDID record UDI-DI 05060472440419

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 506047244BM731V8 registered 19 May 2026 Active
FDA GUDID UDI-DI 05060472440419 listed 4 Oct 2016 Listed

Timeline

2 dated events

4 Oct 2016 Listed FDA GUDID 05060472440419
19 May 2026 Registered EUDAMED 506047244BM731V8

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Tempus Pro Configuration Utility Software EUDAMED
Tempus Pro GUDID
Generic name: Multiple vital physiological parameter monitoring system, clinical
Device name: Tempus Pro Configuration Utility
Model / reference: 01-2501

Primary DI / UDI-DI: 05060472440419
Basic UDI-DI: 506047244BM731V8
FDA product code: MHX
EMDN code: Z1203020299 Multi–parameter monitors - other
GMDN term: Multiple vital physiological parameter monitoring system, clinical

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 870.1025
System or procedure pack: System which is a device in itself
EU registration type: Standard device
EU market of registration: Norway
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED 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.