Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

021955-8461-1720-348 — Class IIa MDD by audifon GmbH & Co. KG

MD Atlas
audifon GmbH & Co. KG

EUDAMED last updated this device on Apr 17, 2026

021955-8461-1720-348

B-021955-8461-1720-34824

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: audifon GmbH & Co. KG
UDI-DI code: D-021955-8461-1720-34824
Reference / catalog number: 021955-8461-1720-348

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

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	Sep 1, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-021955-8461-1720-34824
Basic UDI-DI: B-021955-8461-1720-34824
Reference / catalog number: 021955-8461-1720-348
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: Dome, offen -- KIND UniTip -- Dome 10
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification