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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Actim 1ngeni — IVDR Class A IVDR by Actim Oy

MD Atlas
Actim Oy

EUDAMED last updated this device on May 29, 2022

Actim 1ngeni

643003099ACTIM191015K

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Actim Oy
UDI-DI code: 06430030990837
Reference / catalog number: 19101AC

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Manufacturer information

Organization name: Actim Oy
SRN: FI-MF-000024323
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW273
Risk of electrical shock. Do not operate the instrument or the power supply plug pack if it has been opened, damaged or exposed to moisture, condensation or rain. The external power supply plug pack is sealed with no user serviceable parts. Do not operate this module with any damaged or exposed parts.
CW029
Do not touch the screen with sharp objects.
CW023
Do not use this instrument in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with its proper operation.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: Actim 1ngeni
UDI-DI code: 06430030990837
Basic UDI-DI: 643003099ACTIM191015K
Reference / catalog number: 19101AC
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Actim® 1ngeni is an automated rapid in vitro diagnostic instrument. The instrument has been designed to provide quantitative and/or qualitative results of immunochromatographic colorimetric tests measuring various analytes from patient samples to aid in diagnosis and treatment monitoring. The instrument is intended to be used by healthcare professional in clinical laboratories and near-patient testing (NPT) settings. The instrument is intended to be used with the Actim 1ngeni test kits. Target population is defined by the associated assays. Specimen type is based on the associated assays.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0299IVD INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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