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Eea TRIEEAXL21XTORVIL

by Covidien LP

Part of a family of 24 devices: see the family page

Ref TRIEEAXL21XTORVIL

Eea TRIEEAXL21XTORVIL is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 18 May 2026 (Basic UDI-DI 0763000B00012527J), cleared under FDA 510(k) K232126 on 16 Aug 2023 and listed in FDA GUDID since 7 Feb 2025 (UDI-DI 10884521827646), 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) K232126

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 Number0763000B00012527J Basic UDI-DI 10884521827646UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521827646 UDI-DI Date7 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232126 Date16 Aug 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00012527J registered 18 May 2026 Active
  • FDA 510(k) K232126 decided 16 Aug 2023 Active
  • FDA GUDID UDI-DI 10884521827646 listed 7 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232126
  2. Listed FDA GUDID 10884521827646
  3. Registered EUDAMED 0763000B00012527J

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  • Withdrawn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
Tri-StapleTM, EEATM EUDAMED
Eea GUDID
Generic name
Intraluminal circular stapler, single-use
Device name
EEATM Circular Stapler with Tri-StapleTM
Model / reference
TRIEEAXL21XTORVIL
Primary DI / UDI-DI
10884521827646
Basic UDI-DI
0763000B00012527J
510(k) Number
FDA product code
GDW, GAG
EMDN code
H02030299 Circular staplers for videosurgery – other
GMDN term
Intraluminal circular stapler, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750, 878.4740
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Outer Diameter — 21 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Intraluminal circular stapler, single-use

Cleared under the same submission (K232126)

Similar devices in this category

Other devices filed under STAPLERS FOR VIDEOSURGERY.

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
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)