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Organization name
UDI-DI code
Reference / catalog number

SoKINOX — Class IIb MDR by INOSYSTEMS

MD Atlas
INOSYSTEMS

EUDAMED last updated this device on Jun 20, 2023

SoKINOX

376033338INOTHERAPYEF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INOSYSTEMS
UDI-DI code: 03760333380053
Reference / catalog number: IN000107

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Manufacturer information

Organization name: INOSYSTEMS
SRN: FR-MF-000011282
Manufacturer status: Active

Critical warnings

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

CW027
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Jul 25, 2022	Jul 27, 2027

Device identification

Trade name: SoKINOX
UDI-DI code: 03760333380053
Basic UDI-DI: 376033338INOTHERAPYEF
Reference / catalog number: IN000107
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SoKINOX - appareil configuré ainsi :Langue = Anglais canadien (étiquetage, interface utilisateur, instructions et manuels)Raccord ligne Oxygène de type DISSCâble d’alimentation électrique de type US standardBouteilles KINOX 800ppm [FR]-SoKINOX - device configured as follows:Language = Canadian English (labelling, user interface, instructions and manuals)Oxygen line connection type DISSCable power supply cable type US standardKINOX 800ppm cylinders [EN]
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1203019002NITRIC OXIDE DISPENSERS

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

Related devices

Additional patient tube 10 mm376033338_INO_DELIVERYA7On the market Additional patient tube 15 mm, 1pcs/pkg376033338_INO_DELIVERYA7On the market Additional patient tube 22 mm, 1pcs/pkg376033338_INO_DELIVERYA7On the market Bed rail holder376033338ACCI_INOSUPPORBROn the market ETT connector and adapter 5pcs/pkg376033338_INO_DELIVERYA7On 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.