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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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BTE — 1 UDI-DI variant, MDD (Widex A/S)

MD Atlas
Widex A/S

Data from EUDAMED, last updated May 31, 2026

BTE

B-05706069718287

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: Widex A/S

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UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01K09Z24CE5KW0N05Q5FJ0CRQN

Format

Summary

30 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Market country
Issuing entity
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

HA EVK E-FM 440 SLVGR05706069718287

Device characteristics

Active device

Legacy certificates

Certificate number: G10934610011
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-05706069718287
Device name: —
Device model: BTE
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Jul 16, 2025

Manufacturer & authorised representative

Manufacturer

Name: Widex A/S
SRN: DK-MF-000025153
Country: Denmark
Email: katarzyna.bobrow@wsa.com
Phone: +4544355600

Variants by status