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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-001892QE-CM/V — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Oct 20, 2022

MAD-001892QE-CM/V

8435421200471Y3

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: 08435256794670
Reference / catalog number: MAD-001892QE-CM/V

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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: 08435256794670
Basic UDI-DI: 8435421200471Y3
Reference / catalog number: MAD-001892QE-CM/V
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 formaldehyde fixation completely alters or destroys the immunoreactivity of many antigens and epitopes. The negative effect of the formaldehyde fixation can be successfully reversed for some markers with the enzymatic digestion, while with others, it doesn’t work correctly. Enzyme 1 (Proteinase K Solution) is used to the digestion of tissue sections previously deparaffinized and hydrated with the pepsin enzyme recovers the immunoreactivity of many antigens in fixed tissues.
Additional information URL: https://www.vitro.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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