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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

REM3WRB-S-F — Class IIa MDR by Remedee Labs SA

MD Atlas
Remedee Labs SA

EUDAMED last updated this device on Jul 3, 2025

REM3WRB-S-F

3770015737-REM3WRB-F-3D

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Remedee Labs SA
UDI-DI code: 03770015737198
Reference / catalog number: REM3WRB-S-F

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Manufacturer information

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

Related devices

REM3IOS3770015737-REM3IOS-QROn the market REM3AND3770015737-REM3AND-MFOn the market REM3WRB-L-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.

Critical warnings

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

CW275
The Remedee bracelet has not been tested on a pediatric population (under age of 18) and on pregnant women.
CW010
If in doubt about the use of the device, ask your doctor for advice.
CW274
Remedee Labs advises against using the bracelet on a tattooed wrist or near metal objects such as jewelry or piercings.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03770015737198
Basic UDI-DI: 3770015737-REM3WRB-F-3D
Reference / catalog number: REM3WRB-S-F
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: Endorphin stimulation wristband - Fibromyalgia (F) - size SMALL (S)
Additional information URL: https://fibrorem.remedee.com/manuel-utilisateur
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N010199NEUROPHYSIOLOGY DEVICES - OTHER

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