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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

FSKF46 L — Class I MDR by ARTSANITY SRL

MD Atlas
ARTSANITY SRL

EUDAMED last updated this device on Oct 14, 2025

FSKF46 L

805577665FLYSPLINTCJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ARTSANITY SRL
UDI-DI code: 08058480791408
Reference / catalog number: FSKF46 L

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View device family (Basic UDI)

Manufacturer information

Organization name: ARTSANITY SRL
SRN: IT-MF-000031338
Manufacturer status: Active

Critical warnings

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

CW030
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Sep 8, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058480791408
Basic UDI-DI: 805577665FLYSPLINTCJ
Reference / catalog number: FSKF46 L
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Splint per l'immobilizzazione del ginocchio e piede sinistro pronto all'uso
Additional information URL: https://www.artsanity.it/
Clinical sizes: M (Medium)

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058480791408

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M030599IMMOBILISATION SYSTEMS AND DEVICES - OTHER

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

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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.