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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

Oncoprevia — Class I MDR by Oncosia Scientific GmbH

MD Atlas
Oncosia Scientific GmbH

EUDAMED last updated this device on Sep 25, 2024

Oncoprevia

PP11873ONCOPREVIA31

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oncosia Scientific GmbH
UDI-DI code: 111955197891
Reference / catalog number: Oncoprevia

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Manufacturer information

Organization name: Oncosia Scientific GmbH
SRN: DE-MF-000044353
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 111955197891
Basic UDI-DI: PP11873ONCOPREVIA31
Reference / catalog number: Oncoprevia
Issuing entity: IFA

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Software für die personalisierte Krebsfrüherkennung basierend auf validierten, statistischen Risikoscores.
Additional information URL: https://www.oncosia.de/downloads
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.