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LAIA XR

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: AUGMENTED REALITY SOFTWARE SL
Manufacturer SRN: ES-MF-000044174
UDI-DI: 08437027533006
Basic UDI-DI: 8437027533LAIAXRAS
Reference: v1.0.0
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:17

Manufacturer products View details

Kinesix VR

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Neuro Group XR Inc
Manufacturer SRN: CA-MF-000039639
UDI-DI: 08437027074004
Basic UDI-DI: 8437027074KinesixVRTC
Reference: Kinesix VR
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: PRODUCTO SANITARIO INGENIERÍA Y CONSULTORÍA S.L.
Last updated: 03.07.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Nora

NORA

Class IMDR 2017/745On the marketActive device

Manufacturer: NORAHEALTH, S.L.
Manufacturer SRN: ES-MF-000032124
UDI-DI: 08437025841004
Basic UDI-DI: 8437025841NH013E
Reference: Nora
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:16

Manufacturer products View details

Ailin

AILIN

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Home Diagnostics S.L
Manufacturer SRN: ES-MF-000026858
UDI-DI: 08437024909194
Basic UDI-DI: 843702490919F3
Reference: 18
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:14

Manufacturer products View details

MEDIPVITALS

PLATAFORMA MEDIPVITALS

Class IMDR 2017/745On the marketDirect marking

Manufacturer: MEDIP HEALTH, S.L.
Manufacturer SRN: ES-MF-000014081
UDI-DI: 08437024814009
Basic UDI-DI: 8437024814MV2AY
Reference: MEDIPVITALS
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:14

Manufacturer products View details

Step Proactive

2023_StepProactive_01

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Naru Intelligence Solutions S.L.
Manufacturer SRN: ES-MF-000004006
UDI-DI: 08437024164036
Basic UDI-DI: 84370241642023STEPRO01TN
Reference: 2023_StepProactive_01
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:13

Manufacturer products View details

BIAlert

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ASOCIACIÓN PARA EL DESARROLLO DE LA INGENIERÍA DEL CONOCIMIENTO (ADIC)
Manufacturer SRN: ES-MF-000035725
UDI-DI: 00084370260103
Basic UDI-DI: 8437026010BIALERT86
Reference: BIAlert
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:10

Manufacturer products View details

Result Flagging Module

V2.0

IVD Class AIVDR 2017/746On the market

Manufacturer: Systelab Technologies S.A.
Manufacturer SRN: ES-MF-000000383
UDI-DI: 84370208180562
Basic UDI-DI: 84370208180562L
Reference: 129-MMRF_V2
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:09

Manufacturer products View details

NAIHA

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Ubikare Zainketak S.L.
Manufacturer SRN: ES-MF-000050152
UDI-DI: 84370301460028
Basic UDI-DI: 84352556NAIHAPA
Reference: NAIHA-GESTORA
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:49

Manufacturer products View details

NextCalc

NEXTCALC

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: Evolus Srl
Manufacturer SRN: IT-MF-000046592
UDI-DI: 08059554160007
Basic UDI-DI: 805955416SQ
Reference: NC001
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:27

Manufacturer products View details

80589461100192

POHEMA (versione 2)

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GPI S.P.A.
Manufacturer SRN: IT-MF-000020127
UDI-DI: 80589461100192
Basic UDI-DI: 805894611POHEMA2XN
Reference: POHEMA
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:19

Manufacturer products View details

CAPSULA SOFTWARE 3.X

Capsula Pod 3.0.9

Class IMDR 2017/745On the market

Manufacturer: CAPSULA S.r.l.
Manufacturer SRN: IT-MF-000044675
UDI-DI: 08058946840053
Basic UDI-DI: 805894684CL2QV
Reference: CAPSULA
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:17

Manufacturer products View details

CommunicatorAI

Class IMDR 2017/745On the marketActive device

Manufacturer: Digitherapix S.R.L.
Manufacturer SRN: IT-MF-000054427
UDI-DI: 08058754590010
Basic UDI-DI: 805875459FT2COMAI029V
Reference: 02-COMMUNICATORAI
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

Balbus 5.0

BALBUS 5.0

Class IMDR 2017/745On the marketActive device

Manufacturer: Digitherapix S.R.L.
Manufacturer SRN: IT-MF-000054427
UDI-DI: 08058754590003
Basic UDI-DI: 805875459BALB5.0JB
Reference: 01-BALBUS 5.0
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

H2O CCE

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: AFEA S.R.L.
Manufacturer SRN: IT-MF-000044680
UDI-DI: 08057808170000
Basic UDI-DI: 805780817-H2O+CCE-AZ
Reference: H2O CCE
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:52

Manufacturer products View details

ICON3D®

ICON V1

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Medics Srl
Manufacturer SRN: IT-MF-000007960
UDI-DI: 08057639150004
Basic UDI-DI: 805763915V92TDICON3D2ANF
Reference: ICON3D V1.0.0
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:45

Manufacturer products View details

80574400800028

Kiber Assistant

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: VRMEDIA SRL
Manufacturer SRN: IT-MF-000054046
UDI-DI: 80574400800028
Basic UDI-DI: 805744008KASK4
Reference: KAS-A
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:35

Manufacturer products View details

DOTTORFARMA

.FARMA (anche PUNTOFARMA)

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: QWINCE INNOVATION S.R.L.
Manufacturer SRN: IT-MF-000029688
UDI-DI: 08056897340004
Basic UDI-DI: 805689734.Farma23PZ
Reference: DF01.I
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:22

Manufacturer products View details

TracciaTelcare - Piattaforma di telemedicina

TracciaTelcare

Class IMDR 2017/745On the marketActive device

Manufacturer: COOPERATIVA EDP LA TRACCIA
Manufacturer SRN: IT-MF-000013939
UDI-DI: 08056814800000
Basic UDI-DI: 805681480TELCARE_1MS
Reference: TracciaTelcare
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:21

Manufacturer products View details

LEMO

Class IMDR 2017/745On the marketActive device

Manufacturer: Lemons in the room
Manufacturer SRN: IT-MF-000053057
UDI-DI: 08056638350002
Basic UDI-DI: 805663835LEMO01GD
Reference: LEMO-SW-001
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:19

Manufacturer products View details