EV1000 PC2K: CE/MDR Class IIb, Edwards Lifesciences LLC

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0690103D001HNI000T4 Basic UDI-DI 00690103193473UDI-DI	Date1 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00690103193473 UDI-DI	Date3 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 0690103D001HNI000T4 — open Devices and search for it
AccessGUDID record UDI-DI 00690103193473

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 0690103D001HNI000T4 registered 1 Oct 2026 Active
FDA GUDID UDI-DI 00690103193473 listed 3 Sep 2016 Listed

Timeline

2 dated events

3 Sep 2016 Listed FDA GUDID 00690103193473
1 Oct 2026 Registered EUDAMED 0690103D001HNI000T4

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: EV1000
Generic name: Patient monitoring system module, blood pressure, noninvasive
Device name: HemoSphere Non-Invasive
Model / Ref / Catalog: PC2K

Primary DI / UDI-DI: 00690103193473
Basic UDI-DI: 0690103D001HNI000T4
FDA product code: DSB, DXN, DQK, QAQ, DXG
EMDN code: Z1203020280 Multi-parameter monitors - hardware accessories
GMDN term: Patient monitoring system module, blood pressure, noninvasive

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 870.2770, 870.1130, 870.1425, 870.2210, 870.1435
EU registration type: Standard device
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 IIb	GUDID Class II

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.