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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-FISH-PKII — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Oct 20, 2022

MAD-FISH-PKII

8435421200464Y6

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: 08435256763102
Reference / catalog number: MAD-FISH-PKII

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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: 08435256763102
Basic UDI-DI: 8435421200464Y6
Reference / catalog number: MAD-FISH-PKII
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: Paraffin Tissue FISH Kit II contains reagents to perform fluorescence in situ hybridization (FISH) on buffered formalin-fixed, paraffin-embedded tissue sections, fresh samples and imprints. It is especially recommended for oncohematological and Her2-neu probes.
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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