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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

2.1.z — Class IIa MDR by icometrix

MD Atlas
icometrix

EUDAMED last updated this device on Oct 17, 2024

2.1.z

++B621ICOMPANION24F

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: icometrix
UDI-DI code: +B621ICOMPANION2X1Y0
Reference / catalog number: 2.1.z

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Manufacturer information

Organization name: icometrix
SRN: BE-MF-000006329
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement	Feb 8, 2024	Still on market
Italy	Feb 8, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: +B621ICOMPANION2X1Y0
Basic UDI-DI: ++B621ICOMPANION24F
Reference / catalog number: 2.1.z
Issuing entity: HIBCC

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: —
Additional information URL: https://icompanion.ms/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

Certificates

Certificate health across this manufacturer's portfolio.

BE23/00000345Issued
Quality management systemNotified body: 1639Expiry: Dec 11, 2028

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