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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

114106 — IVDD — General IVDD by Reagena Oy

MD Atlas
Reagena Oy

EUDAMED last updated this device on Dec 15, 2023

114106

B-114106LU

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Reagena Oy
UDI-DI code: D-114106LU
Reference / catalog number: 114106

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Manufacturer information

Organization name: Reagena Oy
SRN: FI-MF-000002804
Manufacturer status: Active

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

1 warning recorded — scroll inside the panel to see all entries.

CW010
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-114106LU
Basic UDI-DI: B-114106LU
Reference / catalog number: 114106
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: ReaScan TBE IgM is a rapid test for qualitative detection of tick-borne encephalitis (TBE, FSME) virus specific IgM antibodies in human serum and cerebrospinal fluid (CSF). The test result is read from the Test cassette with the ReaScan+ reader (REF 105100) (Reagena Oy, Toivala, Finland). The result is used as an aid in the diagnosis of TBE.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105099099VIROLOGY - RT & POC - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

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