Skip to content

AMSure® Endotracheal Tube 1

by Amsino International, Inc. 13 variants

Ref AS72095

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411002536 Basic UDI-DI 10704411002536UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411002536 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3172-2026 FDA Class II initiated 31 Jul 2026

    The 6Fr suction catheter could not pass through the samples smoothly.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
AMSureⓇ Endotracheal Tube EUDAMED
AMSure® Endotracheal Tube GUDID
Generic Name
Basic endotracheal tube, single-use
Device Name
Endotracheal Tube and Accessories
Model / Ref / Catalog
AS72095, 1
Primary DI / UDI-DI
10704411002536
Basic UDI-DI
B-10704411002536
510(k) Number
FDA Product Code
BTR
EMDN Code
R01030201 Endotracheal tubes, cuffed, not reinforced
GMDN Term
Basic endotracheal tube, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5730
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AS72095
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Basic endotracheal tube, single-use

Cleared under the same submission (K042683)

Show all (12)

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No