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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

90400 — Class IIa MDR by Dreve Otoplastik GmbH

MD Atlas
Dreve Otoplastik GmbH

EUDAMED last updated this device on May 27, 2026

90400

++E2390005XY

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dreve Otoplastik GmbH
UDI-DI code: +E239904001
Reference / catalog number: 90400

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View device family (Basic UDI)

Manufacturer information

Organization name: Dreve Otoplastik GmbH
SRN: DE-MF-000005459
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

44911220476Supplemented
Quality management systemNotified body: 0044Expiry: Dec 4, 2028

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: +E239904001
Basic UDI-DI: ++E2390005XY
Reference / catalog number: 90400
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: 1,0 kg
Additional information URL: https://otoplastik.dreve.de/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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