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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-024081RVSBC — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Sep 17, 2025

MAD-024081RVSBC

8435421200478YH

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: 08435804522335
Reference / catalog number: MAD-024081RVSBC

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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: 08435804522335
Basic UDI-DI: 8435421200478YH
Reference / catalog number: MAD-024081RVSBC
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: Pepsin for antigen retrieval (RTU) is a ready-to-use, buffered enzymatic solution designed for the effective retrieval of antigens in formalin-fixed, paraffin-embedded (FFPE) tissue sections. This product is particularly suitable for unmasking antigens that are strongly masked by the extracellular matrix and are not effectively retrieved using standard heat-induced epitope retrieval (HIER) buffers such as citrate, EDTA, or TRIS-EDTA. Pepsin treatment enables improved visualization of specific antigens in immunohistochemical (IHC) applications. The product is designed for use by qualified professionals trained in immunohistochemistry techniques. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
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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