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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

48564 — Class IIa MDR by Dreve Otoplastik GmbH

MD Atlas
Dreve Otoplastik GmbH

EUDAMED last updated this device on May 20, 2026

48564

++E2390007Y4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dreve Otoplastik GmbH
UDI-DI code: +E239485641
Reference / catalog number: 48564

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Manufacturer information

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

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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 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: +E239485641
Basic UDI-DI: ++E2390007Y4
Reference / catalog number: 48564
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: 500 g
Additional information URL: https://otoplastik.dreve.de/
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

Certificates

Certificate health across this manufacturer's portfolio.

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