EUDAMED update: Dec 17, 2025

DGS Diagnostics A/S

DK-MF-000020570

Active176 devices

Address: Audiometer Allé, 1 5500 Middelfart
Role: Manufacturer
Date of registration: Feb 21, 2022
Country: Denmark

DGS Diagnostics A/S is a medical device manufacturer registered in EUDAMED. The company has 176 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Middelfart, Denmark. Explore the regulatory profile, devices and certificates on MD Atlas.

About DGS Diagnostics A/S

: DK-MF-000020570
Role: Manufacturer
Country: Denmark
Organization name: DGS Diagnostics A/S
EU VAT number: 15015446
EORI: DK15015446
Trade register: 15015446
Date of registration: Feb 21, 2022

Contact details for DGS Diagnostics A/S

Email: ra_product-lifecycle@dgs-diagnostics.com
Address: 1, AUDIOMETER ALLÉ 5500 MIDDELFART DENMARK

Data export

Export the 176 devices of DGS Diagnostics A/S

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Competent authority

Name: Danish Medicines Agency, Pharmacovigilance & Medical Devices

Phone: +45 44 88 95 95
Email: dkma@dkma.dk

Officers and regulatory representatives of DGS Diagnostics A/S

RATH Merete Djernæs
Ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released, and for ensuring the post-market surveillance obligations are complied with in accordance with article 10(10) of the (EU) MDR 2017/745. Ensuring that the reporting obligations referred to in articles 87 to 91 of (EU) 2017/745 are fulfilled
Hidden
ANDERSEN Christina
Ensuring that the technical documentation of conformity are drawn up and kept up to date, and that, in the case of investigational devices, the statement referred to in section 4.1 of chapter II of Annex XV of the (EU) 2017/745 is issued.
Hidden

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
B-81	B-81	`8104119`	`05711117219586`	1	On the market
B71	B71	`8102514`	`05711117192056`	1	On the market
CIR insert earphone	CIR insert earphone	`8528954`	`05711117225952`	1	On the market
DD45	DD45	`8010879`	`05711117221671`	1	On the market
DD450	DD450	`8520308`	`05711117228717`	1	On the market
DD65v2	DD65v2	`8520327`	`05711117228779`	1	On the market
RadioEar IP30	RadioEar IP30	`8601097`	`05711117243871`	1	On the market
Sanibel ADI Ear Tip Kit	Sanibel ADI Ear Tip Kit	`8511445`	`05711117198256`	1	On the market
Sanibel ADI eartip sample kit	Sanibel ADI eartip sample kit	`8522207`	`05711117221107`	1	On the market
Sanibel ADI eartip sample kit	Sanibel ADI eartip sample kit	`8524062`	`05711117223101`	1	On the market
Sanibel ADI eartip sample kit	Sanibel ADI eartip sample kit	`8106925`	`05711117208238`	1	On the market
Sanibel ADI Scre. Ear Tip Kit	Sanibel ADI Scre. Ear Tip Kit	`8501572`	`05711117141658`	1	On the market
Sanibel Adult OAE foam ear tips	Sanibel Adult OAE foam ear tips	`8102681`	`05711117199666`	100	On the market
Sanibel Adult OAE foam ear tips	Sanibel Adult OAE foam ear tips	`8515436`	`05711117217162`	20	On the market
Sanibel Alligator clip electrode cable	Sanibel Alligator clip electrode cable	`8535775`	`05711117229011`	1	On the market
Sanibel Alligator clip electrode cable	Sanibel Alligator clip electrode cable	`8535774`	`05711117229004`	1	On the market
Sanibel Alligator clip electrode cable	Sanibel Alligator clip electrode cable	`8535776`	`05711117229028`	1	On the market
Sanibel ANA Infant mushroom ear tip	Sanibel ANA Infant mushroom ear tip	`8106365`	`05711117129267`	50	On the market
Sanibel ANA-Infant Tree	Sanibel ANA-Infant Tree	`8106366`	`05711117129274`	50	On the market
Sanibel Assortment BET55 Complete	Sanibel Assortment BET55 Complete	`8104678`	`05711117211658`	1	On the market
Sanibel Assortment Box	Sanibel Assortment Box	`8029344`	`05711117027600`	1	On the market
Sanibel Assortment Box	Sanibel Assortment Box	`8502555`	`05711117230215`	1	On the market
Sanibel Assortment Box	Sanibel Assortment Box	`8011474`	`05711117099027`	1	On the market
Sanibel Assortment Box BET25	Sanibel Assortment Box BET25	`8012838`	`05711117026504`	1	On the market
Sanibel AuDX Infant ear tip	Sanibel AuDX Infant ear tip	`8515507`	`05711117217247`	20	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
B-81	B-81	`8104119`	`05711117219586`	1	On the market
B71	B71	`8102514`	`05711117192056`	1	On the market
CIR insert earphone	CIR insert earphone	`8528954`	`05711117225952`	1	On the market
DD45	DD45	`8010879`	`05711117221671`	1	On the market
DD450	DD450	`8520308`	`05711117228717`	1	On the market
DD65v2	DD65v2	`8520327`	`05711117228779`	1	On the market
RadioEar IP30	RadioEar IP30	`8601097`	`05711117243871`	1	On the market
Sanibel ADI Ear Tip Kit	Sanibel ADI Ear Tip Kit	`8511445`	`05711117198256`	1	On the market
Sanibel ADI eartip sample kit	Sanibel ADI eartip sample kit	`8522207`	`05711117221107`	1	On the market
Sanibel ADI eartip sample kit	Sanibel ADI eartip sample kit	`8524062`	`05711117223101`	1	On the market
Sanibel ADI eartip sample kit	Sanibel ADI eartip sample kit	`8106925`	`05711117208238`	1	On the market
Sanibel ADI Scre. Ear Tip Kit	Sanibel ADI Scre. Ear Tip Kit	`8501572`	`05711117141658`	1	On the market
Sanibel Adult OAE foam ear tips	Sanibel Adult OAE foam ear tips	`8102681`	`05711117199666`	100	On the market
Sanibel Adult OAE foam ear tips	Sanibel Adult OAE foam ear tips	`8515436`	`05711117217162`	20	On the market
Sanibel Alligator clip electrode cable	Sanibel Alligator clip electrode cable	`8535775`	`05711117229011`	1	On the market
Sanibel Alligator clip electrode cable	Sanibel Alligator clip electrode cable	`8535774`	`05711117229004`	1	On the market
Sanibel Alligator clip electrode cable	Sanibel Alligator clip electrode cable	`8535776`	`05711117229028`	1	On the market
Sanibel ANA Infant mushroom ear tip	Sanibel ANA Infant mushroom ear tip	`8106365`	`05711117129267`	50	On the market
Sanibel ANA-Infant Tree	Sanibel ANA-Infant Tree	`8106366`	`05711117129274`	50	On the market
Sanibel Assortment BET55 Complete	Sanibel Assortment BET55 Complete	`8104678`	`05711117211658`	1	On the market
Sanibel Assortment Box	Sanibel Assortment Box	`8029344`	`05711117027600`	1	On the market
Sanibel Assortment Box	Sanibel Assortment Box	`8502555`	`05711117230215`	1	On the market
Sanibel Assortment Box	Sanibel Assortment Box	`8011474`	`05711117099027`	1	On the market
Sanibel Assortment Box BET25	Sanibel Assortment Box BET25	`8012838`	`05711117026504`	1	On the market
Sanibel AuDX Infant ear tip	Sanibel AuDX Infant ear tip	`8515507`	`05711117217247`	20	On the market

DGS Diagnostics A/S

About DGS Diagnostics A/S

Contact details for DGS Diagnostics A/S

Export the 176 devices of DGS Diagnostics A/S

Competent authority

Officers and regulatory representatives of DGS Diagnostics A/S

Related searches

About DGS Diagnostics A/S

Contact details for DGS Diagnostics A/S

Export the 176 devices of DGS Diagnostics A/S

Competent authority

Officers and regulatory representatives of DGS Diagnostics A/S

Statistics for DGS Diagnostics A/S

Certificate health for DGS Diagnostics A/S

Related documents

Devices by risk class

Market presence of DGS Diagnostics A/S

Device catalog for DGS Diagnostics A/S

Device families (Basic UDI-DI) of DGS Diagnostics A/S

Related searches

Market presence of DGS Diagnostics A/S

Devices by risk class

Statistics for DGS Diagnostics A/S

Certificate health for DGS Diagnostics A/S

Related documents

Device catalog for DGS Diagnostics A/S

Device families (Basic UDI-DI) of DGS Diagnostics A/S