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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

088-0023-00062 — Class IIa MDR by Sonova AG

MD Atlas
Sonova AG

EUDAMED last updated this device on Aug 21, 2023

088-0023-00062

07613389SWAQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sonova AG
UDI-DI code: 07613389581089
Reference / catalog number: 088-0023-00062

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Manufacturer information

Organization name: Sonova AG
SRN: CH-MF-000015958
Manufacturer status: Active

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050-1072-P607613389BTEV7On the market 050-1069-P1 07613389BTEV7On the market 050-1069-P3 07613389BTEV7On the market 050-1078-H007613389BTEV7On the market 0761338960456607613389RICWJOn 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.

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Spain		Still on market
Sweden		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07613389581089
Basic UDI-DI: 07613389SWAQ
Reference / catalog number: 088-0023-00062
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214599HEARING AIDS - OTHER

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