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17.09.2026 18:13

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25 device results listed.

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Össur Logic

BU00099

Class IMDR 2017/745On the marketActive device

Manufacturer: Össur Iceland ehf.
Manufacturer SRN: IS-MF-000000173
UDI-DI: 05690977836785
Basic UDI-DI: 5690967BU00099P6
Reference: BAP01003
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 21:43

Manufacturer products View details

Biosim Pro

BU00104

Class IMDR 2017/745On the marketActive device

Manufacturer: Össur Iceland ehf.
Manufacturer SRN: IS-MF-000000173
UDI-DI: 05690977836754
Basic UDI-DI: 5690967BU00104N6
Reference: Biosim-iOS
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 21:43

Manufacturer products View details

HCAlert

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Hope Care SA
Manufacturer SRN: PT-MF-000002817
UDI-DI: 05600666871812
Basic UDI-DI: 56006668718HCAlert1.3M9
Reference: HCAlert 1.3
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:21

Manufacturer products View details

IBEX BH

IBEX Bone Health Product (IBEX BH)

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: IBEX Innovations Ltd
Manufacturer SRN: GB-MF-000029350
UDI-DI: 05060968750015
Basic UDI-DI: 506096875TVBHPL6
Reference: 5060968750015
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

COVVI GO – iOS

COVVI GO

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: COVVI Ltd
Manufacturer SRN: GB-MF-000033926
UDI-DI: 05060726132404
Basic UDI-DI: 506072613GMN012WZ
Reference: CVGOIO
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Poland
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors View details

ChestLink

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Oxipit, UAB
Manufacturer SRN: LT-MF-000022304
UDI-DI: 04779050430117
Basic UDI-DI: 477905043MDSCL100X8
Reference: 1
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:04

Manufacturer products View details

ChestEye

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Oxipit, UAB
Manufacturer SRN: LT-MF-000022304
UDI-DI: 04779050430100
Basic UDI-DI: 477905043MDSCE220W2
Reference: 2
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: -
Last updated: 31.07.2026 07:04

Manufacturer products View details

04262473810029

RAYLYTIC PROMs

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: RAYLYTIC Software GmbH
Manufacturer SRN: DE-MF-000044964
UDI-DI: 04262473810029
Basic UDI-DI: 4262473810002WE
Reference: RAYLYTIC PROMs
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:39

Manufacturer products View details

BTL CardioPoint

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108590CPMEU00
Basic UDI-DI: ++B108590SWK6
Reference: 590-CP-M
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Northern Ireland
Authorised representative: BTL ITALIA S.r.l.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

BTL CONNECTin

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108550CINMEU00
Basic UDI-DI: ++B108550GM
Reference: 550-CINUNL-M; 550-CIN25U-M; 550-CIN10U-M
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Northern Ireland
Authorised representative: BTL ITALIA S.r.l.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

A1c estimator

Class IMDDOn the marketActive device

Manufacturer: ProWellness Health Solutions Oy
Manufacturer SRN: FI-MF-000009237
UDI-DI: D-FI-MF-000009237-42W
Basic UDI-DI: B-FI-MF-000009237-42W
Reference: D-FI-MF-000009237-42W
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:28

Manufacturer products View details

Bolus Calculator

Class IIbMDDNo longer on the marketActive deviceAdministering medicine

Manufacturer: ProWellness Health Solutions Oy
Manufacturer SRN: FI-MF-000009237
UDI-DI: D-FI-MF-000009237-12Q
Basic UDI-DI: B-FI-MF-000009237-12Q
Reference: D-FI-MF-000009237-12Q
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:28

Manufacturer products View details

Balansio

Class IMDDOn the marketActive device

Manufacturer: ProWellness Health Solutions Oy
Manufacturer SRN: FI-MF-000009237
UDI-DI: D-FI-MF-000009237-32U
Basic UDI-DI: B-FI-MF-000009237-32U
Reference: D-FI-MF-000009237-32U
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:28

Manufacturer products View details

D-FI-MF-000009237-22S

ProWellness Chronic Diseases Management System

Class IMDDOn the marketActive device

Manufacturer: ProWellness Health Solutions Oy
Manufacturer SRN: FI-MF-000009237
UDI-DI: D-FI-MF-000009237-22S
Basic UDI-DI: B-FI-MF-000009237-22S
Reference: D-FI-MF-000009237-22S
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:28

Manufacturer products View details

ARIA

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DataRiver S.r.l.
Manufacturer SRN: IT-MF-000038324
UDI-DI: 08052570750009
Basic UDI-DI: 805257075MHC007W
Reference: ARIA
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:31

Manufacturer products View details

OneTouch Reveal Insulin Mentor

Class IIaMDR 2017/745On the marketActive device

Manufacturer: LifeScan U.S. LLC
Manufacturer SRN: US-MF-000018448
UDI-DI: 07613427029979
Basic UDI-DI: 76134277029974F
Reference: 024167
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: LifeScan Deutschland GmbH
Last updated: 03.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

Haemoassist

Haemoassist 3

Class IMDR 2017/745On the marketActive device

Manufacturer: StatConsult IT-Service GmbH
Manufacturer SRN: DE-MF-000007901
UDI-DI: 04260738540568
Basic UDI-DI: 426073854HA3XX-XXX75
Reference: n/a
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:07

Manufacturer products View details

Haemoassist Mobile

HGM Haemoassist Mobile

Class IMDR 2017/745On the marketActive device

Manufacturer: StatConsult IT-Service GmbH
Manufacturer SRN: DE-MF-000007901
UDI-DI: 04260738540551
Basic UDI-DI: 426073854HGMXX-XXXPY
Reference: n/a
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:07

Manufacturer products View details

QTT Solution

Class IMDR 2017/745On the marketActive device

Manufacturer: MedClinik SAS
Manufacturer SRN: FR-MF-000009359
UDI-DI: 03770021452023
Basic UDI-DI: 3770021452AFL1111XSD000FB
Reference: M0213
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:59

Manufacturer products View details

Seattle-Groningen Memory Assessment

SGMA

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MemoryLab Health BV
Manufacturer SRN: NL-MF-000051668
UDI-DI: 08720892886200
Basic UDI-DI: 10084934SGMA019T
Reference: SGMA-STD
EMDN: Z129082
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 11:06

Manufacturer products View details