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Trachstay 11270

by B&B Medical Technologies, Inc

Ref 11270

Trachstay 11270 is a Class I device made by B&B Medical Technologies, Inc, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0085000873311270UP) and listed in FDA GUDID since 24 Mar 2020 (UDI-DI 00850008733185), 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 Number0085000873311270UP Basic UDI-DI 00850008733185UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850008733185 UDI-DI Date24 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0085000873311270UP registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00850008733185 listed 24 Mar 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 00850008733185
  2. Registered EUDAMED 0085000873311270UP

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  • Withdrawn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
Trachstay
Generic name
Tracheostomy tube neck holder, single-use
Model / Ref / Catalog
11270
Primary DI / UDI-DI
00850008733185
Basic UDI-DI
0085000873311270UP
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)