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Organization name
UDI-DI code
Reference / catalog number

4-motion® knee tibial component — Class III MDD by ARTIQO GmbH

MD Atlas
ARTIQO GmbH

EUDAMED last updated this device on Aug 16, 2022

4-motion® knee tibial component

B-04251143404477

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ARTIQO GmbH
UDI-DI code: 04251143404477
Reference / catalog number: 3631-R001

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Manufacturer information

Organization name: ARTIQO GmbH
SRN: DE-MF-000007336
Manufacturer status: Active

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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.

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 Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 21, 2022	Still on market

Device identification

Trade name: 4-motion® knee tibial component
UDI-DI code: 04251143404477
Basic UDI-DI: B-04251143404477
Reference / catalog number: 3631-R001
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.artiqo.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P090903020105BICOMPARTMENTAL PRIMARY IMPLANT UNCEMENTED FIXED BEARING TIBIAL PLATES

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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Software identification