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AG Cuffil

by Hospitech Respiration Ltd.

Ref HSCUFF0041Model AG Cuffill Model HSCUFF0041 Measurement Range 0-99 cmH2O

AG Cuffil (HSCUFF0041) is an endotracheal tube cuff inflator (EU MDR Class I; FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Hospitech Respiration Ltd, registered in EUDAMED on 7 Apr 2026 (Basic UDI-DI 1729001540900TT), cleared under FDA 510(k) K122721 on 3 May 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 17290015409008), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122721

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1729001540900TT Basic UDI-DI 17290015409008UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17290015409008 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122721 Date3 May 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 1729001540900TT registered 7 Apr 2026 Active
  • FDA 510(k) K122721 decided 3 May 2013 Active
  • FDA GUDID UDI-DI 17290015409008 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122721
  2. Listed FDA GUDID 17290015409008
  3. Registered EUDAMED 1729001540900TT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
AG Cuffill (cmH2O)
Generic name
Endotracheal tube cuff inflator
Model / Ref / Catalog
AG Cuffill Model HSCUFF0041 Measurement Range 0-99 cmH2O, HSCUFF0041
Primary DI / UDI-DI
17290015409008 EUDAMED
07290015409001 GUDID
Basic UDI-DI
1729001540900TT
510(k) Number
FDA product code
BSK
EMDN code
R01038001, V0399
GMDN term
Endotracheal tube cuff inflator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5750
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
17290015409008
GUDID
07290015409001
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 17290015409008; FDA GUDID lists 07290015409001), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IL-MF-000018143
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS.

Other devices from Hospitech Respiration Ltd

See all devices from Hospitech Respiration Ltd →

Properties

  • Reusable
  • Reprocessed single-use device
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)