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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

ORT01002 — Class I MDR by NOVANKLE

MD Atlas
NOVANKLE

EUDAMED last updated this device on Apr 3, 2026

ORT01002

0069905100058449Q

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NOVANKLE
UDI-DI code: 37700343150182
Reference / catalog number: ORT01002

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Manufacturer information

Organization name: NOVANKLE
SRN: FR-MF-000038041
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Sep 4, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 37700343150182
Basic UDI-DI: 0069905100058449Q
Reference / catalog number: ORT01002
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: M

EMDN nomenclature code(s)

Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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

ORT010030069905100058449QOn the market ORT010010069905100058449QOn the market

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.