Hose 1000380: EU MDR Class I registered 2026

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number880931567IPCTUBING4F Basic UDI-DI 08809802640689UDI-DI	Date13 Jul 2026Registered	StatusActive
United States	GUDID listing GUDID	Number08809802640689 UDI-DI	Date17 Dec 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK202395	Date1 Sep 2021Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK203498	Date2 Jul 2021Decided	StatusActive
United States	FDA 510(k) GUDID from GUDID	NumberK203019	Date22 Jun 2021Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI 880931567IPCTUBING4F — open Devices and search for it
AccessGUDID record UDI-DI 08809802640689
FDA 510(k) database 510(k) number K202395
FDA 510(k) database 510(k) number K203498
FDA 510(k) database 510(k) number K203019

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 880931567IPCTUBING4F registered 13 Jul 2026 Active
FDA 510(k) K202395 decided 1 Sep 2021 Active· +2 more in the status table
FDA GUDID UDI-DI 08809802640689 listed 17 Dec 2021 Listed

Timeline

5 dated events

22 Jun 2021 Cleared FDA 510(k) K203019
2 Jul 2021 Cleared FDA 510(k) K203498
1 Sep 2021 Cleared FDA 510(k) K202395
17 Dec 2021 Listed FDA GUDID 08809802640689
13 Jul 2026 Registered EUDAMED 880931567IPCTUBING4F

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Withdrawn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: Hose
Generic name: Intermittent venous compression system
Device name: IPC Tubing
Model / reference: 1000380

Primary DI / UDI-DI: 08809802640689
Basic UDI-DI: 880931567IPCTUBING4F
510(k) Number: K202395
K203019
K203498
FDA product code: IRP
EMDN code: Z12069080 Various physiotherapy and rehabilitation instruments - hardware accessories
GMDN term: Intermittent venous compression system

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 890.5650
EU registration type: Standard device
EU market of registration: Spain
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.