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Nellcor EASYCAP II

by Covidien LP

Ref EASYCAPII

Nellcor EASYCAP II is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 0763000B00000587D) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521084032), active as of 23 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00000587D Basic UDI-DI 10884521084032UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521084032 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00000587D registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 10884521084032 listed 24 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 10884521084032
  2. Registered EUDAMED 0763000B00000587D

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  • Withdrawn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
Nellcor
Generic name
Exhaled-gas oesophageal intubation detector
Device name
Easycap/Pedicap
Model / reference
EASYCAPII EUDAMED
EASYCAP II GUDID
Primary DI / UDI-DI
10884521084032
Basic UDI-DI
0763000B00000587D
FDA product code
CCK
EMDN code
R018099 Intubation devices - accessories not included in other classes - other
GMDN term
Exhaled-gas oesophageal intubation detector
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.1400
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
EASYCAPII
GUDID
EASYCAP II
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Exhaled-gas oesophageal intubation detector

Similar devices in this category

Other devices filed under INTUBATION DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Covidien LP

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  • Shiley 110870

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See all devices from Covidien LP →

Properties

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