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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

FIA-1709 — IVDR Class A IVDR by FIANOSTICS GmbH

MD Atlas
FIANOSTICS GmbH

EUDAMED last updated this device on Jul 24, 2023

FIA-1709

PP10748W0201029962

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: FIANOSTICS GmbH
UDI-DI code: 111883077184
Reference / catalog number: FIA-1709

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Manufacturer information

Organization name: FIANOSTICS GmbH
SRN: AT-MF-000025705
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 111883077184
Basic UDI-DI: PP10748W0201029962
Reference / catalog number: FIA-1709
Issuing entity: IFA

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: Metallverstärkter Fluoreszenzimmunoassay (MEF-FIA) zum quantitativen Nachweis von 25-Hydroxy-Vitamin D [25(OH)D] in humanem Serum und Kapillartrockenblut
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102070206VITAMIN D (CHOLECALCIFEROL)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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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.