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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

30800ETAC — IVDD — General IVDD by Actim Oy

MD Atlas
Actim Oy

EUDAMED last updated this device on Feb 24, 2023

30800ETAC

B-6430030990110SZ

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-6430030990110SZ
Reference / catalog number: 30800ETAC

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Manufacturer information

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

Critical warnings

3 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.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement		Still on market
Estonia		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-6430030990110SZ
Basic UDI-DI: B-6430030990110SZ
Reference / catalog number: 30800ETAC
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: Actim® PROM Controls are intended to be used with the Actim® PROM test for external quality control. The controls may also be used to demonstrate negative results and weak and strong positive results.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160801CONTROLS IMMUNOCHEM - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.