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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

2140 — Class IIa MDR by SYSTEM ASSISTANCE MEDICAL

MD Atlas
SYSTEM ASSISTANCE MEDICAL

EUDAMED last updated this device on Apr 15, 2026

2140

3700368621401UX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SYSTEM ASSISTANCE MEDICAL
UDI-DI code: 03700368622469
Reference / catalog number: 2140

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Manufacturer information

Organization name: SYSTEM ASSISTANCE MEDICAL
SRN: FR-MF-000003517
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03700368622469
Basic UDI-DI: 3700368621401UX
Reference / catalog number: 2140
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: SYST'AM Ultrasonic Nebulizer - Humidifier LS2000+, delivered with case, includes 1L bottle and carrying case (without heater)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R060101COLD NEBULISATION SYSTEMS

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

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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.