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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-103.020 — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Feb 17, 2023

MAD-103.020

8435421200558YG

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: 08435421257146
Reference / catalog number: MAD-103.020

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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: 08435421257146
Basic UDI-DI: 8435421200558YG
Reference / catalog number: MAD-103.020
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 Orcein Stain Kit has been designed for use in both manual and automated histological staining on the MD-Stainer for the qualitative identification of Hepatitis B surface Antigen (HBsAg), elastic fibers, and copper associated proteins in formalin-fixed, paraffin-embedded human tissue samples.
Additional information URL: https://www.vitro.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030711IMMUNOHISTOLOGY KITS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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