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Tracheal Tube Introducer

by Create Biotech Co., Ltd.

Ref 023-002-1014

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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
United StatesGUDID listing GUDID Number04719874951061 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-04719874951061 Basic UDI-DI 04719874951061UDI-DIDate24 Jun 2026RegisteredStatusActive

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.

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  • Withdrawn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
Create Biotech
Generic Name
Artificial airway stylet, single-use
Device Name
Tracheal Tube Introducer
Model / Reference
023-002-1014
Primary DI / UDI-DI
04719874951061
Basic UDI-DI
B-04719874951061
FDA Product Code
BSR
EMDN Code
R018004 Intubation device guides
GMDN Term
Artificial airway stylet, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5790
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
TW-MF-000021770
Authorised representative
JOUMED TECHNOLOGY OÜ EE-AR-000012526

Other devices from Create Biotech Co., Ltd.

See all devices from Create Biotech Co., Ltd. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • 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
  • Serial Number: No