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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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20 device results listed.

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FraiyaScan

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Fraiya Ltd
Manufacturer SRN: UK-MF-000045978
UDI-DI: 05061081480018
Basic UDI-DI: 5061081485061081480001Q5
Reference: FraiyaScan
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Trium CTG Online

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Trium Analysis Online GmbH
Manufacturer SRN: DE-MF-000007016
UDI-DI: 04260346620010
Basic UDI-DI: 426034662TriumCTGOnlineQU
Reference: 002001E-02-4
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:54

Manufacturer products View details

B-Right Views Fetal Heart

BrightHeart View Classifier (B-Right Views Fetal Heart)

Class IIaMDR 2017/745On the market

Manufacturer: BrightHeart
Manufacturer SRN: FR-MF-000044855
UDI-DI: 03760415600031
Basic UDI-DI: 376041560BVCMD01AM
Reference: BVCMD01
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details

B-Right Screen Fetal Heart

Fetal EchoScan (B-Right Screen Fetal Heart)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: BrightHeart
Manufacturer SRN: FR-MF-000044855
UDI-DI: 03760415600024
Basic UDI-DI: 376041560FESMD01BC
Reference: FESMD01
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details

IntelliSpace Perinatal K Small Arch.

IntelliSpace Perinatal

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838084490
Basic UDI-DI: B-00884838084490
Reference: 867062
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 05.07.2026 12:05

Manufacturer products View details

IntelliSpace Perinatal K Large Arch.

IntelliSpace Perinatal

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838084483
Basic UDI-DI: B-00884838084483
Reference: 867061
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 05.07.2026 12:05

Manufacturer products View details

astraia neon

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748856000
Basic UDI-DI: 426074885astneonCL
Reference: 1.0.x
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:09

Manufacturer products View details

astraia – software for women's health - obstetric and gynaecological database application

astraia – software for women's health

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748850008
Basic UDI-DI: 426074885ASTRAIASC
Reference: 1.27.4
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:09

Manufacturer products View details

03770033463024

FETOLY

Class IIaMDR 2017/745No longer on the marketDirect markingMeasuring function

Manufacturer: DIAGNOLY
Manufacturer SRN: FR-MF-000037822
UDI-DI: 03770033463024
Basic UDI-DI: 3770033463FETOLYv2ZB
Reference: FETOLY
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details

03770033463000

FETOLY-HEART

Class IIaMDR 2017/745No longer on the marketDirect marking

Manufacturer: DIAGNOLY
Manufacturer SRN: FR-MF-000037822
UDI-DI: 03770033463000
Basic UDI-DI: 3770033463FETOLY4K
Reference: FETOLY-HEART
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:14

Manufacturer products View details

Sonio Suspect

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Sonio
Manufacturer SRN: FR-MF-000018467
UDI-DI: 03770024341034
Basic UDI-DI: 3770024341SuspectS6
Reference: v1
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:05

Manufacturer products View details

Sonio Detect

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Sonio
Manufacturer SRN: FR-MF-000018467
UDI-DI: 03770024341027
Basic UDI-DI: 3770024341DetectMM
Reference: v1
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:05

Manufacturer products View details

Sonio Detect

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Sonio
Manufacturer SRN: FR-MF-000018467
UDI-DI: 03770024341041
Basic UDI-DI: 3770024341DetectMM
Reference: v2
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 27.06.2026 05:21

Manufacturer products View details

03770033463031

Class IIaMDR 2017/745No longer on the marketDirect markingMeasuring function

Manufacturer: DIAGNOLY
Manufacturer SRN: FR-MF-000037822
UDI-DI: 03770033463031
Basic UDI-DI: 3770033463FETOLYv2ZB
Reference: FETOLY
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 27.06.2026 05:20

Manufacturer products View details

FETOLY

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: DIAGNOLY
Manufacturer SRN: FR-MF-000037822
UDI-DI: 03770033463048
Basic UDI-DI: 3770033463FETOLYv2ZB
Reference: FETOLY
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 27.06.2026 05:20

Manufacturer products View details

astraia – software for women's health

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748850046
Basic UDI-DI: 426074885ASTRAIASC
Reference: 30.00.xx, 30.01.xx
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 22.06.2026 11:05

Manufacturer products View details

Trium CTG Online

Class IIbNot specifiedOn the market

Manufacturer: Trium Analysis Online GmbH
Manufacturer SRN: DE-MF-000007016
UDI-DI: 04260346620072
Basic UDI-DI: 426034662TriumCTGOnlineQU
Reference: 002001C-05
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 20.06.2026 17:23

Manufacturer products View details

astraia – software for women's health

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748850039
Basic UDI-DI: 426074885ASTRAIASC
Reference: 29.02.00
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:22

Manufacturer products View details

astraia – software for women's health

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748850022
Basic UDI-DI: 426074885ASTRAIASC
Reference: 29.01.00
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:22

Manufacturer products View details

astraia – software for women's health - obstetric and gynaecological database application

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748850015
Basic UDI-DI: 426074885ASTRAIASC
Reference: 29.00.00
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:22

Manufacturer products View details