Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SEPSI-SCORE — Class I MDD by PREVIA MEDICAL

MD Atlas
PREVIA MEDICAL

EUDAMED last updated this device on Feb 18, 2026

SEPSI-SCORE

B-FRMF000039701SSUH

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PREVIA MEDICAL
UDI-DI code: D-FRMF000039701SSUH
Reference / catalog number: SEPSI-SCORE

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: PREVIA MEDICAL
SRN: FR-MF-000039701
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
The SEPSI-SCORE cannot be used for patients under 18 years old
CW010
It is a prognostic score that requires confirmation by a trained healthcare professional. It cannot be used to confirm a diagnosis.

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: SEPSI-SCORE
UDI-DI code: D-FRMF000039701SSUH
Basic UDI-DI: B-FRMF000039701SSUH
Reference / catalog number: SEPSI-SCORE
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The SEPSI-SCORE is a medical software tool that provides alerts to highlight patients who may be at risk of developing sepsis. It consists of two key components: the PREVIA Score, responsible for fetching, analyzing, and calculating scores, and the PREVIA Alert, a tool for viewing and interpreting these scores.
Additional information URL: No additional information URL provided by the manufacturer.
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.