Skip to content

Dar 350U5865

by Covidien LP

Ref 350U5865

Dar 350U5865 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 0763000B00026098C) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20884522032589), 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 Number0763000B00026098C Basic UDI-DI 20884522032589UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20884522032589 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00026098C registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 20884522032589 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20884522032589
  2. Registered EUDAMED 0763000B00026098C

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  • Withdrawn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
Microbial medical gas filter, single-use
Device name
Electrostatic Filter (Non-Sterile)
Model / reference
350U5865
Primary DI / UDI-DI
20884522032589
Basic UDI-DI
0763000B00026098C
FDA product code
CAH
EMDN code
R040101 Antibacterial and antiviral respiratory filters
GMDN term
Microbial medical gas filter, single-use
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: Microbial medical gas filter, single-use

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    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)