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Hamilton-C1 1610010

by Hamilton Medical AG

Ref 1610010

Hamilton-C1 1610010 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 76300028PN16100104V) and listed in FDA GUDID since 26 Jan 2022 (UDI-DI 07630002813426), active as of 9 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300028PN16100104V Basic UDI-DI 07630002813426UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630002813426 UDI-DI Date26 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300028PN16100104V registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 07630002813426 listed 26 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630002813426
  2. Registered EUDAMED 76300028PN16100104V

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  • Withdrawn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
Hamilton-C1
Generic name
Neonatal/adult intensive-care ventilator
Model / Ref / Catalog
1610010
Primary DI / UDI-DI
07630002813426
Basic UDI-DI
76300028PN16100104V
FDA product code
CBK, BZR, DQA
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Neonatal/adult intensive-care ventilator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5895, 868.5330, 870.2700
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: Neonatal/adult intensive-care ventilator

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Hamilton Medical AG

See all devices from Hamilton Medical AG →

Properties

  • Administering medicine
  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)