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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

SE002 — IVDR Class A IVDR by Vircell, S.L

MD Atlas
Vircell, S.L

EUDAMED last updated this device on Oct 24, 2025

SE002

843661029SE002015K

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Vircell, S.L
UDI-DI code: 08436610290401
Reference / catalog number: SE002

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Manufacturer information

Organization name: Vircell, S.L
SRN: ES-MF-000004099
Manufacturer status: Active

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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.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08436610290401
Basic UDI-DI: 843661029SE002015K
Reference / catalog number: SE002
Issuing entity: GS1

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: Nucleic Acid Extraction kit to isolate and purify nucleic acids from human biological specimens based on nanomagnetic bead technology. The purified DNA/RNA is suitable for downstream PCR applications.
Additional information URL: https://www.vircell.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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