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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-000237QP-100/V — IVDR Class A IVDR by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on May 9, 2022

MAD-000237QP-100/V

8435421200455Y5

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: 08435421229020
Reference / catalog number: MAD-000237QP-100/V

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Manufacturer information

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

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: 08435421229020
Basic UDI-DI: 8435421200455Y5
Reference / catalog number: MAD-000237QP-100/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: "Master Polymer Plus Detection System (Peroxidase) is elaborated with the technology of micropolymers, facilitates the detection of antigens in the different cellular compartments (nucleus, cytoplasm and cytoplasmic membrane) due to the smaller size of the molecule. This Kit is specially designed for its handling in the automatic immunostainers MD-Stainer using primary monoclonal or polyclonal antibodies."
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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.