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Shiley 8CN85ES

by Covidien LP

Ref 8CN85ES

Shiley 8CN85ES is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 0763000B00004047A), cleared under FDA 510(k) K193077 on 1 Jun 2020 and listed in FDA GUDID since 11 Jun 2020 (UDI-DI 10884521726437), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193077

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00004047A Basic UDI-DI 10884521726437UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521726437 UDI-DI Date11 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193077 Date1 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00004047A registered 21 Jul 2026 Active
  • FDA 510(k) K193077 decided 1 Jun 2020 Active
  • FDA GUDID UDI-DI 10884521726437 listed 11 Jun 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193077
  2. Listed FDA GUDID 10884521726437
  3. Registered EUDAMED 0763000B00004047A

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Shiley
Generic name
Tracheostomy tube, non-reinforced, non-customized, single-use
Device name
Shiley Evac Single Cannula
Model / reference
8CN85ES
Primary DI / UDI-DI
10884521726437
Basic UDI-DI
0763000B00004047A
510(k) Number
FDA product code
JOH
EMDN code
R0105020101 Tracheostomic cannulas, cuffed, not reinforced, with fixed flange, and kits
GMDN term
Tracheostomy tube, non-reinforced, non-customized, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Outer Diameter — 12.2 Millimeter
Length — 79 Millimeter
Angle — 90 degree

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Tracheostomy tube, non-reinforced, non-customized, single-use

Cleared under the same submission (K193077)

and 8 more cleared under K193077

Similar devices in this category

Other devices filed under INTUBATION DEVICES.

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
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)