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Organization name
UDI-DI code
Reference / catalog number

iAudiogram® — Class IIa MDR by MY MEDICAL ASSISTANT

MD Atlas
MY MEDICAL ASSISTANT

Manufacturer information

Organization name: MY MEDICAL ASSISTANT
SRN: FR-MF-000019847
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

MDR 00127-AIssued
Quality management systemNotified body: 0476Expiry: Mar 2, 2030

Related devices

This device is not currently linked to any other device.

EUDAMED last updated this device on Mar 5, 2025

iAudiogram®

3770025150LOGAUDIOPODV7

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MY MEDICAL ASSISTANT
UDI-DI code: 03770025150000
Reference / catalog number: iAudiogram®

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Manufacturer information

Organization name: MY MEDICAL ASSISTANT
SRN: FR-MF-000019847
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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	Mar 5, 2025	Still on market

Device identification

Trade name: iAudiogram®
UDI-DI code: 03770025150000
Basic UDI-DI: 3770025150LOGAUDIOPODV7
Reference / catalog number: iAudiogram®
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: —
Additional information URL: https://www.iaudiogram.com/community
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12149092VARIOUS ENT 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

Related devices

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

MDR 00127-AIssued
Quality management systemNotified body: 0476Expiry: Mar 2, 2030