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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-HS12 — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on May 18, 2022

VIT-HS12

8435421200439Y7

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: 08435256794892
Reference / catalog number: VIT-HS12

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Manufacturer information

Organization name: VITRO, S.A.
SRN: ES-MF-000001498
Manufacturer status: Active

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: 08435256794892
Basic UDI-DI: 8435421200439Y7
Reference / catalog number: VIT-HS12
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 hybriSpot12 is a new semiautomatic platform that has all the requirements to perform a reverse hybridization of DNA or proteins on a porous membrane by applying an upright vacuum flow at a selected temperature. The platform is based on the DNA-Flow technology. The application of the vacuum flow allows the fast binding between the target molecules fixed on the membrane and the test sample in a three-dimensional porous environment, which substantially increases the binding effectiveness between both molecules and decreases the incubation times to a few minutes, 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

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
Serial number
Software identification

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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.