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Invotec Tracheal T-Tube 1

by Invotec International, Inc. 10 variants

Ref 70-50100

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081850102TrachealtubeQG Basic UDI-DI 00818501020072UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818501020072 UDI-DI Date3 Jan 2017ListedStatusListed 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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Invotec Tracheal T-Tube
Generic Name
Laryngectomy tube, non-sterile
Model / Ref / Catalog
70-50100, 1
Primary DI / UDI-DI
00818501020072
Basic UDI-DI
081850102TrachealtubeQG
510(k) Number
FDA Product Code
BTR
EMDN Code
Q0399 ENT devices - other
GMDN Term
Laryngectomy tube, non-sterile
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5730
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
70-50100
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K930114)

Show all (9)

Other devices from Invotec International, Inc.

See all devices from Invotec International, Inc. →

Properties

  • Lot / Batch Number

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No