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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

GELA NOIR T42 — Class I MDR by GIBAUD

MD Atlas
GIBAUD

EUDAMED last updated this device on Mar 31, 2026

GELA NOIR T42

332254057L3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GIBAUD
UDI-DI code: 03322541081940
Reference / catalog number: 8462-42

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Manufacturer information

Organization name: GIBAUD
SRN: FR-MF-000014279
Manufacturer status: Active

Related devices

GELA NOIR T35332254057L3On the market GELA NOIR T36332254057L3On the market GELA NOIR T37332254057L3On the market GELA NOIR T38332254057L3On the market GELA NOIR T39332254057L3On 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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW030
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: GELA NOIR T42
UDI-DI code: 03322541081940
Basic UDI-DI: 332254057L3
Reference / catalog number: 8462-42
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

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