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Trachealator Non-occlusive Airway Dilation Balloon Catheter

by DISA Medinotec 9 variants

Ref TRD1-14540

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06009698453161 UDI-DI Date20 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0600969845TRD14E Basic UDI-DI 06009698453161UDI-DIDate19 Nov 2025RegisteredStatusActive

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 25 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  • Withdrawn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
Trachealator Non-occlusive Airway Dilation Balloon
Generic Name
Bronchial balloon catheter
Device Name
Trachealator Non-occlusive Airway Dilation Balloon Catheter
Model / Reference
TRD1-14540
Primary DI / UDI-DI
06009698453161
Basic UDI-DI
0600969845TRD14E
510(k) Number
FDA Product Code
KTI
EMDN Code
R050201 Bronchial dilation catheters
GMDN Term
Bronchial balloon catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.4680
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 14.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
ZA-MF-000009024
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from DISA Medinotec

See all devices from DISA Medinotec →

Properties

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

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No