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

Odontoscope Application — Class I MDR by BENOLIEL SIMON FSBD

MD Atlas
BENOLIEL SIMON FSBD

EUDAMED last updated this device on Dec 4, 2025

Odontoscope Application

54199804938ODONTOAPP01KH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BENOLIEL SIMON FSBD
UDI-DI code: 05419980493811
Reference / catalog number: V1.1

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: BENOLIEL SIMON FSBD
SRN: BE-MF-000043630
Manufacturer status: Active

Related devices

01054199805419980493804BAOn 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.

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: Odontoscope Application
UDI-DI code: 05419980493811
Basic UDI-DI: 54199804938ODONTOAPP01KH
Reference / catalog number: V1.1
Issuing entity: GS1

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: The Odontoscope Application is intended to support the structured documentation of oral health examinations in nursing homes and care institutions. It allows the user to record clinical findings, organise intra-oral photographs taken with the Odontoscope® mirror, generate a clinical report, and securely transmit the data to a dentist for remote review when needed. The application does not perform automated analysis, diagnosis, interpretation, triage, or clinical decision support. All clinical decisions remain fully under the responsibility of the healthcare professional.
Additional information URL: https://odontoscope.com/fr/instructions.aspx
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