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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

7001 — IVDR Class A IVDR by 4bases SA

MD Atlas
4bases SA

EUDAMED last updated this device on May 28, 2026

7001

764041338700X3V

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: 4bases SA
UDI-DI code: 76404133800668
Reference / catalog number: 7001

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View device family (Basic UDI)

Manufacturer information

Organization name: 4bases SA
SRN: CH-MF-000042125
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 76404133800668
Basic UDI-DI: 764041338700X3V
Reference / catalog number: 7001
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 UDI Primer Set is an accessory intended for use with in vitro diagnostic (IVD) systems employing hybrid capture-based next-generation sequencing (NGS) library preparation workflows for Illumina and Oxford Nanopore sequencing platforms. The device consists of a set of primers containing unique dual index (UDI) barcode sequences used during library preparation to enable the identification of individual samples during sequencing. The indexes are incorporated into DNA fragments during a pre-capture amplification. The combination of these indexes allows the unique identification of samples and supports multiplex sequencing, enabling multiple samples to be processed within the same sequencing run. The device does not perform any diagnostic analysis and does not generate clinical or diagnostic results.
Additional information URL: https://cloud.4bases.ch/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)76404133800668

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.