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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

021957-002-8430-358 — Class IIa MDD by audifon GmbH & Co. KG

MD Atlas
audifon GmbH & Co. KG

EUDAMED last updated this device on Apr 10, 2026

021957-002-8430-358

B-021957-002-8430-358KJ

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: audifon GmbH & Co. KG
UDI-DI code: D-021957-002-8430-358KJ
Reference / catalog number: 021957-002-8430-358

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Manufacturer information

Organization name: audifon GmbH & Co. KG
SRN: DE-MF-000008355
Manufacturer status: Active

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033264-A006-1720-358B-033264-A006-1720-358XMOn the market 033264-A006-1720-357B-033264-A006-1720-357XKOn the market 033262-A004-1720-357B-033262-A004-1720-357STOn the market 033262-A004-1720-358B-033262-A004-1720-358SVOn the market 021955-8461-1720-351B-021955-8461-1720-351ZNOn 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

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 22, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-021957-002-8430-358KJ
Basic UDI-DI: B-021957-002-8430-358KJ
Reference / catalog number: 021957-002-8430-358
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: Hörereinheit S -- audifon -- Länge: 0 -- rechts
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214580HEARING AIDS OR HEARING DEVICES - ACCESSORIES

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

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Manufacturing date
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Software identification