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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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HI (BTE) — 610 UDI-DI variants, MDR (SBO Hearing A/S)

MD Atlas
SBO Hearing A/S

Data from EUDAMED, last updated May 31, 2026

HI (BTE)

57144640-HI-000015-WT

610 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

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 57144640-HI-000015-WT
Device name: —
Device model: HI (BTE)
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Aug 16, 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

610 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01J5DF1YSDNSYCA1GBV1GV5WDC

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

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