Tempus Pro 01-2186: CE/MDD Class I

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-05060472441140 Basic UDI-DI 05060472441140UDI-DI	Date19 May 2026Registered	StatusActive
United States	GUDID listing GUDID	Number05060472441140 UDI-DI	Date16 Jan 2018Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI B-05060472441140 — open Devices and search for it
AccessGUDID record UDI-DI 05060472441140

Across registries

2 registries list this device

EUDAMED Basic UDI-DI B-05060472441140 registered 19 May 2026 Active
FDA GUDID UDI-DI 05060472441140 listed 16 Jan 2018 Listed

Timeline

2 dated events

16 Jan 2018 Listed FDA GUDID 05060472441140
19 May 2026 Registered EUDAMED B-05060472441140

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Tempus Pro Printer Paper with 110mm Grid EUDAMED
Tempus Pro GUDID
Generic name: Multiple vital physiological parameter monitoring system, clinical
Device name: Gridded Printer Paper
Model / reference: 01-2186

Primary DI / UDI-DI: 05060472441140
Basic UDI-DI: B-05060472441140
FDA product code: MHX
EMDN code: Z12050385 Electrocardiographs - consumables
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: Legacy device (under a directive)
EU market of registration: Netherlands
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.