# Hamilton-C6 160021 > Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Hamilton Medical AG](https://devicerts.com/manufacturers/hamilton-medical-ag) (Switzerland) - Name in the registry: HAMILTON-C6 160021 - Device class: Class IIb (EU MDR); Class II (US FDA) - FDA product code: CBK - EMDN: R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER - GMDN: Neonatal/adult intensive-care ventilator (42411) ## Registrations and authorizations - **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 76300028PN160021ZW · UDI-DI 07630002808590 · registered 2026-09-02 · status: Active - **GUDID** · GUDID listing · United States · UDI-DI 07630002808590 · listed 2022-01-26 · status: Listed (GUDID: in commercial distribution) - **GUDID** · FDA 510(k) · United States · K201658 · decision 2020-12-11 · decision SESE · status: Active · from GUDID ## Recalls - Z-2328-2025 · Class I · ongoing · initiated 2025-06-03: A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation. - Z-2020-2024 · Class I · ongoing · initiated 2024-05-15: Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator. - Z-1429-2023 · Class II · ongoing · initiated 2023-03-14: Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational. - Z-0267-2023 · Class II · ongoing · initiated 2022-09-22: Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again. - Z-1525-2022 · Class I · ongoing · initiated 2022-06-27: Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed ## Identity - Trade name: HAMILTON-C6 [EUDAMED, FDA GUDID (AccessGUDID)] - Generic name: Neonatal/adult intensive-care ventilator [FDA GUDID (AccessGUDID)] - Model / Ref / Catalog: 160021 [EUDAMED, FDA GUDID (AccessGUDID)] ## Identifiers - Primary DI / UDI-DI: 07630002808590 [EUDAMED, FDA GUDID (AccessGUDID)] - Basic UDI-DI: 76300028PN160021ZW [EUDAMED] - 510(k) Number: K201658 [FDA GUDID (AccessGUDID)] - FDA product code: CBK [FDA GUDID (AccessGUDID)] - EMDN code: R9099 [EUDAMED] - GMDN term: Neonatal/adult intensive-care ventilator (42411) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)] - Regulation number: 868.5895 [FDA GUDID (AccessGUDID)] - EU registration type: Standard device [EUDAMED] - EU market of registration: Austria [EUDAMED] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Clinical & Handling - MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)] ## Properties - Administering medicine: Yes [EUDAMED] - Measuring function: Yes [EUDAMED] - Prescription use: Yes [FDA GUDID (AccessGUDID)] - Serial number: Yes [FDA GUDID (AccessGUDID)] - Manufacturing date: Yes [FDA GUDID (AccessGUDID)] - Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)] - Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)] - Single use: No [FDA GUDID (AccessGUDID)] - Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)] - Reusable: No [EUDAMED] - Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)] - Reprocessed single-use device: No [EUDAMED] - Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED] - Incorporates a substance derived from human blood or plasma: No [EUDAMED] - Contains human tissues or cells: No [EUDAMED] - Contains animal tissues or cells: No [EUDAMED] - Contains endocrine-disrupting substances: No [EUDAMED] - Incorporates a medicinal substance: No [EUDAMED] - Over-the-counter: No [FDA GUDID (AccessGUDID)] - Convenience kit: No [FDA GUDID (AccessGUDID)] - Combination product: No [FDA GUDID (AccessGUDID)] - HCT/P: No [FDA GUDID (AccessGUDID)] - Premarket exempt: No [FDA GUDID (AccessGUDID)] - Lot / batch number: No [FDA GUDID (AccessGUDID)] - Expiration date: No [FDA GUDID (AccessGUDID)] ## Source and citation - Cite as: Hamilton-C6 160021, Hamilton Medical AG. deviCERTS medical device catalogue. https://devicerts.com/devices/hamilton-c6-160021 (data as of 2026-11-15). - Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-11-09 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/hamilton-c6-160021 - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.