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Trachguard 11250

by B&B Medical Technologies, Inc

Ref 11250

Trachguard 11250 is a Class I device made by B&B Medical Technologies, Inc, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0085000873311250UH) and listed in FDA GUDID since 20 Jan 2020 (UDI-DI 00850008733093), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0085000873311250UH Basic UDI-DI 00850008733093UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850008733093 UDI-DI Date20 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0085000873311250UH registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00850008733093 listed 20 Jan 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850008733093
  2. Registered EUDAMED 0085000873311250UH

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  • Withdrawn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
Trachguard
Generic name
Tracheostomy tube neck holder, single-use
Model / Ref / Catalog
11250
Primary DI / UDI-DI
00850008733093
Basic UDI-DI
0085000873311250UH
FDA product code
CBH
EMDN code
R018002 Intubation device supports
GMDN term
Tracheostomy tube neck holder, single-use
Device class
Class I
Regulation number
868.5770
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tracheostomy tube neck holder, single-use

Similar devices in this category

Other devices filed under INTUBATION DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from B&B Medical Technologies, Inc

See all devices from B&B Medical Technologies, Inc →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)