Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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.

OneApp — 4 UDI-DI variants, MDR (SBO Hearing A/S)

MD Atlas
SBO Hearing A/S

Data from EUDAMED, last updated May 23, 2026

OneApp

57144640-ONEAPP-00087-KQ

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: SBO Hearing A/S

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?

Device characteristics

Active device

Identity & classification

Basic UDI-DI: 57144640-ONEAPP-00087-KQ
Device name: —
Device model: OneApp
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Special device type: refdata.special-mdr-device-type.software
Version date: Jul 8, 2024

Manufacturer & authorised representative

Manufacturer

Name: SBO Hearing A/S
SRN: DK-MF-000001270
Country: Denmark
Email: info@demant.com
Phone: +45 3917 7100

Variants by status

UDI-DI variants

4 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01J28ZFWH3ZFHN3MXCMXCE4TMP

Format

Summary

29 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
Placed on the market (country)
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

27491105714464146024
27048905714464139439
28607905714464175543
28502605714464168095