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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

3415 — Class IIa MDR by SYSTEM ASSISTANCE MEDICAL

MD Atlas
SYSTEM ASSISTANCE MEDICAL

EUDAMED last updated this device on Apr 15, 2026

3415

3700368634171W5

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SYSTEM ASSISTANCE MEDICAL
UDI-DI code: 03700368610701
Reference / catalog number: 3415

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Manufacturer information

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

Related devices

SYST'AM P111MPPMHI37003686P111MHI1Z7On the market P301C40431HW37003686P301CHW1YYOn the market P301C43431HW37003686P301CHW1YYOn the market P301C46461HW37003686P301CHW1YYOn the market P302C43431HW37003686P302CHW1ZBOn 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	Jan 1, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03700368610701
Basic UDI-DI: 3700368634171W5
Reference / catalog number: 3415
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 Pack of 6 × 1L Bottles for Humidification
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0401CLINICAL USE BOTTLES

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
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