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Ambu A/S 321000702

by VBM Medizintechnik GmbH

Part of a family of 6 devices: see the family page

Ref 321000702

Ambu A/S 321000702 is an endotracheal tube cuff inflator (EU MDR Class I; FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by VBM Medizintechnik GmbH, registered in EUDAMED on 11 Mar 2026 (Basic UDI-DI 42501056-1.1.5-V3), cleared under FDA 510(k) K912723 on 20 Jul 1991 and listed in FDA GUDID since 26 Mar 2018 (UDI-DI 04250105628081), active as of 23 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 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K912723

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42501056-1.1.5-V3 Basic UDI-DI 04250105628081UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250105628081 UDI-DI Date26 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK912723 Date20 Jul 1991DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 42501056-1.1.5-V3 registered 11 Mar 2026 Active
  • FDA 510(k) K912723 decided 20 Jul 1991 Active
  • FDA GUDID UDI-DI 04250105628081 listed 26 Mar 2018 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K912723
  2. Listed FDA GUDID 04250105628081
  3. Registered EUDAMED 42501056-1.1.5-V3

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  • Withdrawn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
Ambu® Connecting Tube for Cuff Pressure Gauge Length: 100 cm ; female Luer Lock, male Luer EUDAMED
Ambu A/S GUDID
Generic name
Endotracheal tube cuff inflator
Device name
Cuff Pressure Gauges - Acc. Cuff Pressure Gauges
Model / reference
321000702
Primary DI / UDI-DI
04250105628081
Basic UDI-DI
42501056-1.1.5-V3
510(k) Number
FDA product code
BSK
EMDN code
R01038001 Endotracheal tube cuffs inflation systems
GMDN term
Endotracheal tube cuff inflator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5750
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 100 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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.

Related devices

Category: Endotracheal tube cuff inflator

Cleared under the same submission (K912723)

and 1 more cleared under K912723

Similar devices in this category

Other devices filed under ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS.

Other devices from VBM Medizintechnik GmbH

See all devices from VBM Medizintechnik GmbH →

Properties

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