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

SUMO — Class I MDD by CORTEXX MEDICAL…

MD Atlas
CORTEXX MEDICAL INTELLIGENCE

EUDAMED last updated this device on Sep 10, 2024

SUMO

B-03770025018003

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: CORTEXX MEDICAL INTELLIGENCE
UDI-DI code: 03770025018003
Reference / catalog number: SUMO-2.0

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: CORTEXX MEDICAL INTELLIGENCE
SRN: FR-MF-000041199
Manufacturer status: Active

Critical warnings

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

CW030
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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: SUMO
UDI-DI code: 03770025018003
Basic UDI-DI: B-03770025018003
Reference / catalog number: SUMO-2.0
Issuing entity: GS1

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: Standalone medical software for a Machine Learning-Based Predictive Model of Outcome after lumbar decompression surgery Device not custom-made or intended for clinical investigations + Class IIa device
Additional information URL: https://storage.googleapis.com/sumo-assets/documents/Requirements%20%E2%80%A2%20Instructions%20For%20Use%20(IFU)%20-%20FR%20-%20SUMO%20V2.02.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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.