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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

30831RETAC — IVDD — General IVDD by Actim Oy

MD Atlas
Actim Oy

EUDAMED last updated this device on Feb 22, 2023

30831RETAC

B-6430030990554U9

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Actim Oy
UDI-DI code: D-6430030990554U9
Reference / catalog number: 30831RETAC

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Manufacturer information

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

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30372ETACB-6430030990042T9On the market 32732ETACB-6430030990219TQOn the market 31900ETALB-6430030990547UCOn the market Actim 1ngeni643003099ACTIM191015KOn the market 19116IC643003099ACTIM191165YOn the market

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.

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-6430030990554U9
Basic UDI-DI: B-6430030990554U9
Reference / catalog number: 30831RETAC
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 10 test kit. The Actim® PROM 1ngeni test is a qualitative immunochromatographic dipstick test for the detection of amniotic fluid in vaginal secretions during pregnancy. Actim PROM 1ngeni detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
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Software identification