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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

Re5 Neuro Treatment System — Class IIa MDR by Re5 ApS

MD Atlas
Re5 ApS

EUDAMED last updated this device on Jun 18, 2024

Re5 Neuro Treatment System

5745000441NTS02XD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Re5 ApS
UDI-DI code: 05745000441099
Reference / catalog number: I2010-1/a

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View device family (Basic UDI)

Manufacturer information

Organization name: Re5 ApS
SRN: DK-MF-000017805
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Jun 12, 2024	Jun 11, 2029

Device identification

Trade name: Re5 Neuro Treatment System
UDI-DI code: 05745000441099
Basic UDI-DI: 5745000441NTS02XD
Reference / catalog number: I2010-1/a
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: The intended purpose of Re5 Neuro Treatment System is to use Pulsed Electromagnetic Field Stimulation (PEMF) for treatment of adult patients with depression. It can be used in hospitals, clinics and for home use. The product is certified as Class IIa by TÜV SÜD. Certificate, number G10 117853 0002 Rev.00
Additional information URL: https://www.tuvsud.com/en/services/product-certification/ps-cert?q=cert:G10
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05745000441099

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12101105MAGNETIC STIMULATORS

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

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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.