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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

Sangle de maintien trachéale… — Class I MDR by ORTHOMEDICA

MD Atlas
ORTHOMEDICA

EUDAMED last updated this device on May 13, 2026

Sangle de maintien trachéale TRACE Enfant

3665012DUOSANGTRACUB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTHOMEDICA
UDI-DI code: 03665012001277
Reference / catalog number: TRACE (ENFANT)

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Manufacturer information

Organization name: ORTHOMEDICA
SRN: FR-MF-000001811
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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 13, 2026	Still on market

Device identification

Trade name: Sangle de maintien trachéale TRACE Enfant
UDI-DI code: 03665012001277
Basic UDI-DI: 3665012DUOSANGTRACUB
Reference / catalog number: TRACE (ENFANT)
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: Sangle de maintien trachéale destinée au maintien des canules trachéostomiques.
Additional information URL: https://www.orthomedica.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R01058001TRACHEOSTOMIC CANNULAS SUPPORTS

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

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