Dar 354U5876: CE/MDR Class IIa, Covidien LP

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0763000B00026037Y Basic UDI-DI 10884521829176UDI-DI	Date17 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	Number10884521829176 UDI-DI	Date1 Sep 2023Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 0763000B00026037Y — open Devices and search for it
AccessGUDID record UDI-DI 10884521829176

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 0763000B00026037Y registered 17 Jun 2026 Active
FDA GUDID UDI-DI 10884521829176 listed 1 Sep 2023 Listed

Timeline

2 dated events

1 Sep 2023 Listed FDA GUDID 10884521829176
17 Jun 2026 Registered EUDAMED 0763000B00026037Y

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Dar
Generic name: Heat/moisture exchanger/microbial medical gas filter
Device name: Mechanical Filter HME (Non-Sterile)
Model / reference: 354U5876

Primary DI / UDI-DI: 10884521829176
Basic UDI-DI: 0763000B00026037Y
FDA product code: BYD
EMDN code: R040102 Antibacterial and antiviral respiratory filters humidifiers
GMDN term: Heat/moisture exchanger/microbial medical gas filter

Device class: Class IIa EUDAMED
Class I GUDID
Regulation number: 868.5375
EU registration type: Standard device
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

MRI safety: MR Safe

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.