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Hamilton-BC8022 260161

by Hamilton Medical AG

Ref 260161

Hamilton-BC8022 260161 is a device classified as Class IIb in the EU and Class II in the US made by Hamilton Medical AG, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 76300028PN2601612X), cleared under FDA 510(k) K152029 on 3 May 2016 and listed in FDA GUDID since 4 Oct 2016 (UDI-DI 07630002801560), active as of 9 Nov 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 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152029

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300028PN2601612X Basic UDI-DI Date2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630002801560 UDI-DI Date4 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152029 Date3 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76300028PN2601612X registered 2 Sep 2026 Active
  • FDA 510(k) K152029 decided 3 May 2016 Active
  • FDA GUDID UDI-DI 07630002801560 listed 4 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152029
  2. Listed FDA GUDID 07630002801560
  3. Registered EUDAMED 76300028PN2601612X

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  • Withdrawn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
HAMILTON-BC8022, breathing circuit set, dual limb, heated with water chamber EUDAMED
Hamilton-BC8022 GUDID
Generic name
Ventilator breathing circuit, single-use
Model / Ref / Catalog
260161
Primary DI / UDI-DI
07630002801560, 17630002801567
Basic UDI-DI
76300028PN2601612X
510(k) Number
FDA product code
BZE
EMDN code
R060201 Active ventilation humidification systems,
GMDN term
Ventilator breathing circuit, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5270
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Ventilator breathing circuit, single-useInspiratory line humidification chamber, single-use

Cleared under the same submission (K152029)

Similar devices in this category

Other devices filed under ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,.

Other devices from Hamilton Medical AG

See all devices from Hamilton Medical AG →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)