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

REM3IOS — Class IIa MDR by Remedee Labs SA

MD Atlas
Remedee Labs SA

EUDAMED last updated this device on Jul 3, 2025

REM3IOS

3770015737-REM3IOS-QR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Remedee Labs SA
UDI-DI code: 03770015737259
Reference / catalog number: REM3IOS

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: Remedee Labs SA
SRN: FR-MF-000035489
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 14, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770015737259
Basic UDI-DI: 3770015737-REM3IOS-QR
Reference / catalog number: REM3IOS
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Accessory to the Remedee wristband (OA/F), with which it communicates via Bluetooth.
Additional information URL: https://novirem.remedee.com/manuel-utilisateur%20;%20https://fibrorem.remedee.com/manuel-utilisateur
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N010180NEUROPHYSIOLOGY DEVICES - ACCESSORIES

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

REM3AND3770015737-REM3AND-MFOn the market REM3WRB-L-F3770015737-REM3WRB-F-3DOn the market REM3WRB-S-F3770015737-REM3WRB-F-3DOn the market REM3WRB-L-A3770015737-REM3WRB-OA-WEOn the market REM3WRB-S-A3770015737-REM3WRB-OA-WEOn 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.