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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

BIODY XPERTZM 3 — Class IIa MDR by AMINOGRAM

MD Atlas
AMINOGRAM

EUDAMED last updated this device on Jul 3, 2024

BIODY XPERTZM 3

3760073650003WU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AMINOGRAM
UDI-DI code: 03760073650003
Reference / catalog number: BX3

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Manufacturer information

Organization name: AMINOGRAM
SRN: FR-MF-000000671
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW011
Ne pas faire de mesure sur les femmes enceintes ni sur les patients porteurs d'un dispositif électronique de survie (ex: stimulateur cardiaque))

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jul 3, 2024	Still on market
Spain	Jul 3, 2024	Still on market

Device identification

Trade name: BIODY XPERTZM 3
UDI-DI code: 03760073650003
Basic UDI-DI: 3760073650003WU
Reference / catalog number: BX3
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dispositif de mesures de Bioimpédances Analyse de la composition corporelle
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12099001BODY IMPEDANCE ANALYSERS

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

This device is not currently linked to any other device.

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.