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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

GXD5 Diagnostics 1.9 — Class IIa MDD by ENOVACOM

MD Atlas
ENOVACOM

EUDAMED last updated this device on Mar 17, 2022

GXD5 Diagnostics 1.9

B-GXD5DIAGSGH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ENOVACOM
UDI-DI code: D-GXD5DIAGSGH
Reference / catalog number: GXD5 Diagnostics 1.9

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Manufacturer information

Organization name: ENOVACOM
SRN: FR-MF-000000686
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 16, 2021	May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: D-GXD5DIAGSGH
Basic UDI-DI: B-GXD5DIAGSGH
Reference / catalog number: GXD5 Diagnostics 1.9
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Software for medical imaging visualization and interpretation of multi-modalities studies with dedicated tools (measurement of distances, angles and densities)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

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.

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