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

4545M — Class IIa MDR by Dreve Otoplastik GmbH

MD Atlas
Dreve Otoplastik GmbH

EUDAMED last updated this device on May 21, 2026

4545M

++E2390051Y7

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dreve Otoplastik GmbH
UDI-DI code: +E2394545M1
Reference / catalog number: 4545M

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

Related devices

8801BR++E2390051Y7On the market 456++E2390051Y7On the market 743++E2390051Y7On the market 452++E2390051Y7On the market 475BR++E2390051Y7On the market

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: +E2394545M1
Basic UDI-DI: ++E2390051Y7
Reference / catalog number: 4545M
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 x 50 ml Doppelkartusche
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

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.