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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

Autoplak Advance — IVDR Class A IVDR by SENER Diagnostics S.A.

MD Atlas
SENER Diagnostics S.A.

EUDAMED last updated this device on Apr 25, 2024

Autoplak Advance

8437024289Autoplak01BG

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: SENER Diagnostics S.A.
UDI-DI code: 08437024289012
Reference / catalog number: Autoplak Advance

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Manufacturer information

Organization name: SENER Diagnostics S.A.
SRN: ES-MF-000030726
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: 08437024289012
Basic UDI-DI: 8437024289Autoplak01BG
Reference / catalog number: Autoplak Advance
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: IVD no ETL
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W020305PLATES STREAKING EQUIPMENT (STREAKER/ INCUBATOR/ READER)

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

Related devices

Autoplak Advance ETL8437024289Autoplak01BGOn the market Autoplak Complete 8437024289Autoplak01BGOn the market

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.