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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

1069.4CA L — Class I MDR by Footlogics Europe B.V.

MD Atlas
Footlogics Europe B.V.

EUDAMED last updated this device on May 7, 2025

1069.4CA L

8721161974FTLSCOMFORTV4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Footlogics Europe B.V.
UDI-DI code: 08721161974000
Reference / catalog number: 1069.4CA L

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View device family (Basic UDI)

Manufacturer information

Organization name: Footlogics Europe B.V.
SRN: NL-MF-000043504
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.

CW011
Do not use this product in cases of acute pain without prior consultation with a healthcare professional. Adaptation to the insole may require a gradual adjustment period; it is recommended to begin with short durations and progressively increase usage to allow the body to adapt.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08721161974000
Basic UDI-DI: 8721161974FTLSCOMFORTV4
Reference / catalog number: 1069.4CA 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: 2
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08721161974000

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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.

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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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