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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

SW-ONCOANALYZ — IVDD — General IVDD by Oncomedics SAS

MD Atlas
Oncomedics SAS

EUDAMED last updated this device on Jan 20, 2025

SW-ONCOANALYZ

B-FRMF000041783ANALYZERJZ

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Oncomedics SAS
UDI-DI code: D-FRMF000041783ANALYZERJZ
Reference / catalog number: SW-ONCOANALYZ

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Manufacturer information

Organization name: Oncomedics SAS
SRN: FR-MF-000041783
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-FRMF000041783ANALYZERJZ
Basic UDI-DI: B-FRMF000041783ANALYZERJZ
Reference / catalog number: SW-ONCOANALYZ
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Oncomedics Analyzer is intended to be used by laboratory professional as an in vitro diagnostic interpretive software program with image analysis algorithms. The Oncomedics Analyzer is intended to be used in combination with Oncogramme parameters, to assist in the analysis of clinical specimens for the quantitative and qualitative detection of cells (dead vs alive).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010282LIMITED PANEL CELL COUNTING ANALYSERS - SOFTWARE ACCESSORIES

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

OncogrammeB-FRMF000041783ONCOGRAMPAOn 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.