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Organization name
UDI-DI code
Reference / catalog number

REM3CHC-M — Class I MDR by Remedee Labs SA

MD Atlas
Remedee Labs SA

EUDAMED last updated this device on Jul 3, 2025

REM3CHC-M

3770015737-REM3CHC-LU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Remedee Labs SA
UDI-DI code: 03770015737150
Reference / catalog number: REM3CHC-M

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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-S-F3770015737-REM3WRB-F-3DOn the market REM3WRB-L-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.

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: 03770015737150
Basic UDI-DI: 3770015737-REM3CHC-LU
Reference / catalog number: REM3CHC-M
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: Charging case of the Remedee wristband OA/F
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
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Software identification