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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

FOOTPRINT MAKER — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Feb 12, 2025

FOOTPRINT MAKER

84355156PEDIGRAFO1001G2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08435515600032
Reference / catalog number: 1001

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Manufacturer information

Organization name: Flexor S.A.
SRN: ES-MF-000042891
Manufacturer status: Active

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 Spain; available across 1 country total.

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

Device identification

Trade name: FOOTPRINT MAKER
UDI-DI code: 08435515600032
Basic UDI-DI: 84355156PEDIGRAFO1001G2
Reference / catalog number: 1001
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: The footprint taker is intended for taking footprints and the evaluation of the morphological characteristics of the foot, as part of the clinical assessment aimed at supporting the design, adjustment, or manufacture of orthopedic devices. It is intended to be used exclusively by healthcare professionals or under their supervision.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1399NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.