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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

Earsil 2 x 660 g grey — Class IIa MDR by DETAX GmbH & Co. KG

MD Atlas
DETAX GmbH & Co. KG

EUDAMED last updated this device on Nov 24, 2021

Earsil 2 x 660 g grey

++EDET0185R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DETAX GmbH & Co. KG
UDI-DI code: +EDET022461
Reference / catalog number: 02246 / 10950927

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Manufacturer information

Organization name: DETAX GmbH & Co. KG
SRN: DE-MF-000005995
Manufacturer status: Inactive

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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.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market
Luxembourg		Still on market

Device identification

Trade name: Earsil 2 x 660 g grey
UDI-DI code: +EDET022461
Basic UDI-DI: ++EDET0185R
Reference / catalog number: 02246 / 10950927
Issuing entity: HIBCC

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)

Q030499OTOLOGY DEVICES - 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