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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

114403 — IVDD — General IVDD by Reagena Oy

MD Atlas
Reagena Oy

EUDAMED last updated this device on Dec 18, 2023

114403

B-114403M5

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-114403M5
Reference / catalog number: 114403

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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-114403M5
Basic UDI-DI: B-114403M5
Reference / catalog number: 114403
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: Reagena C6 LYME IgM/IgG EIA is an enzyme immunoassay intended for the qualitative detection of Borrelia burgdorferi specific IgM and IgG antibodies in human serum and cerebrospinal fluid (CSF). The result is used as an aid in diagnosis of Lyme borreliosis (LB).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010602LYME ANTIBODY TOTAL

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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