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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

114313 — IVDD — General IVDD by Reagena Oy

MD Atlas
Reagena Oy

EUDAMED last updated this device on Dec 15, 2023

114313

B-114313M3

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-114313M3
Reference / catalog number: 114313

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Manufacturer information

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

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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-114313M3
Basic UDI-DI: B-114313M3
Reference / catalog number: 114313
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+ C6 LYME IgG test is an immunochromatographic rapid test intended for qualitative detection of Borrelia burgdorferi specific IgG antibodies in human serum and cerebrospinal fluid (CSF). The result is used as an aid in diagnosis of Lyme borreliosis (LB). The test result is read from the test cassette with the ReaScan+ reader (105100, Reagena Oy, Finland).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090199BACTERIOLOGY - 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
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

CR-04-1235-886-25Issued
refdata.certificate-ivdr-type.quality-management-systemNotified body: 0537Expiry: Sep 22, 2030