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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

114302 — IVDD — General IVDD by Reagena Oy

MD Atlas
Reagena Oy

EUDAMED last updated this device on Dec 18, 2023

114302

B-114302LW

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-114302LW
Reference / catalog number: 114302

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Manufacturer information

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

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 Slovenia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-114302LW
Basic UDI-DI: B-114302LW
Reference / catalog number: 114302
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 DOBRAVA-HANTAAN IgG EIA is an enzyme immunoassay for detection of Dobrava and Hantaan virus IgG antibodies in human serum
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105040614HANTAVIRUS / BUNYAVIRUS

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

Certificate health across this manufacturer's portfolio.

CR-04-1235-886-25Issued
Quality management systemNotified body: 0537Expiry: Sep 22, 2030