Organization name

Hamilton Bonaduz AG

SRN

CH-MF-000013585

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Moving Parts
• CW273

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW008

  Biohazard Warning

Primary placement in Austria; available across 32 countries total.

Trade name

Clinical NGS STARlet

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07630032643246

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

76300326806691N3

Reference / catalog number

806691

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.hamiltoncompany.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W02060199ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER

• IVDR Class A medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.