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Dar 355U5427

by Covidien LP

Ref 355U5427

Dar 355U5427 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 0763000B00026027W) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884522034296), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00026027W Basic UDI-DI 10884522034296UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884522034296 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00026027W registered 31 Jul 2026 Active
  • FDA GUDID UDI-DI 10884522034296 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884522034296
  2. Registered EUDAMED 0763000B00026027W

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • 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  • Withdrawn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
Electrostatic Filter HME (Non-Sterile)
Model / reference
355U5427
Primary DI / UDI-DI
10884522034296
Basic UDI-DI
0763000B00026027W
FDA product code
CAH
EMDN code
R040102 Antibacterial and antiviral respiratory filters humidifiers
GMDN term
Heat/moisture exchanger/microbial medical gas filter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5260
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

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Heat/moisture exchanger/microbial medical gas filter

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS.

Other devices from Covidien LP

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    Class II

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    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)