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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

VIT-HS24A — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Feb 15, 2023

VIT-HS24A

8435421200569YM

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VITRO, S.A.
UDI-DI code: 08435421269538
Reference / catalog number: VIT-HS24A

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Manufacturer information

Organization name: VITRO, S.A.
SRN: ES-MF-000001498
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: 08435421269538
Basic UDI-DI: 8435421200569YM
Reference / catalog number: VIT-HS24A
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: The hybriSpot 24PCR Auto is a platform capable of fully automating the amplification, denaturation, and hybridization processes, bringing together all the technical specifications that are necessary to facilitate the work to the customer and obtain high performance and efficiency. The platform is based on the DNA-FLOW technology offering a diagnostic system for rapid and simultaneous analyses of multiple biomarkers, DNA as well as proteins through reverse dot blot on macroarrays. This technology allows the target molecules to cross the chip through vertical flow to hybridize to its complementary probes immobilized in a porous matrix in a three-dimensional environment, as opposed to the hybridization on a conventional surface.
Additional information URL: https://www.vitro.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02079099VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

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Sterilization

Lifecycle

New device

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