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Dar 332/5316

by Covidien LP

Part of a family of 56 devices: see the family page

Ref 332/5316

Dar 332/5316 is a device classified as Class IIa in the EU and Class I in the US made by Covidien LP, registered in EUDAMED on 17 Jun 2026 (Basic UDI-DI 0763000B000260686) and listed in FDA GUDID since 9 Mar 2025 (UDI-DI 10884522020213), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000260686 Basic UDI-DI 10884522020213UDI-DIDate17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884522020213 UDI-DI Date9 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000260686 registered 17 Jun 2026 Active
  • FDA GUDID UDI-DI 10884522020213 listed 9 Mar 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884522020213
  2. Registered EUDAMED 0763000B000260686

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  • Withdrawn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
Breathing circuit catheter mount, single-use
Model / reference
332/5316
Primary DI / UDI-DI
10884522020213
Basic UDI-DI
0763000B000260686
FDA product code
BZA
EMDN code
R020201 Fixed catheter mounts
GMDN term
Breathing circuit catheter mount, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5810
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 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.

Related devices

Category: Breathing circuit catheter mount, single-use

Similar devices in this category

Other devices filed under FIXED CATHETER MOUNTS.

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

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)