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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

MAD-SCM-K — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Apr 27, 2022

MAD-SCM-K

8435421200492YB

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: 08435421255760
Reference / catalog number: MAD-SCM-K

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Manufacturer information

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

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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: 08435421255760
Basic UDI-DI: 8435421200492YB
Reference / catalog number: MAD-SCM-K
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: Kit toma saliva para PCR COVID-19 is a saliva collection kit for the detection of respiratory pathogens.
Additional information URL: https://www.vitro.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019002SALIVA COLLECTION DEVICES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification

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.