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HydraFacial

HydraFacial MD Elite

Class IIaMDR 2017/745On the market

Manufacturer: Hydrafacial, LLC
Manufacturer SRN: US-MF-000004431
UDI-DI: 00810007531311
Basic UDI-DI: 081000753ELI7D
Reference: 70290-03-01
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: France
Authorised representative: E C REP LIMITED
Last updated: 30.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

HydraFacial

74111

Class IMDR 2017/745On the marketSingle use

Manufacturer: Hydrafacial, LLC
Manufacturer SRN: US-MF-000004431
UDI-DI: 00810007530895
Basic UDI-DI: 081000753TIP9V
Reference: 70218
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: France
Authorised representative: E C REP LIMITED
Last updated: 30.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

ProBP 2000 Digital Blood Pressure System

902123

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-PR-000047671
UDI-DI: 00732094252781
Basic UDI-DI: 0732094GMN902123F6
Reference: 2000-P
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 19:46

Manufacturer products View details

Welch Allyn

901045

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00732094213379
Basic UDI-DI: 0732094GMN901045F4
Reference: NEO-5-2
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Welch Allyn Limited
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

FlexiPort

901044

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00732094186918
Basic UDI-DI: 0732094GMN901044F2
Reference: VINYL-13
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Welch Allyn Limited
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Welch Allyn

901093

Class IMDR 2017/745On the marketActive device

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00732094136869
Basic UDI-DI: 0732094GMN901093FF
Reference: 77714
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Welch Allyn Limited
Last updated: 30.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Welch Allyn

901043

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00732094002362
Basic UDI-DI: 0732094GMN901043EY
Reference: 47-23-189
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Welch Allyn Limited
Last updated: 30.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

AI-Rad companion Brain MR

MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04068151033977
Basic UDI-DI: 0405686902008UZ
Reference: 11830481
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

myCoro Scout FFR

MDR_01_IIa_FOR_ACDV_FACE

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151012309
Basic UDI-DI: 0405686902307VE
Reference: 11108440
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

00853023006975

i.s.h.med

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006975
Basic UDI-DI: 00853023006i.s.h.medKU
Reference: 10402294
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Oracle Nederland BV
Last updated: 30.07.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006678

Oracle Health General Laboratory

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006678
Basic UDI-DI: 00853023006GLQE
Reference: 10000136
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Oracle Nederland BV
Last updated: 30.07.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

Oracle Health Transfusion Adminstration and Oracle Health Bridge Specimen Collection

Oracle Health Transfusion Administration and Oracle Health Bridge Specimen Collection

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006104
Basic UDI-DI: 0085302300OHTABSCY7
Reference: 10000038 10000039
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Oracle Nederland BV
Last updated: 30.07.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

00850017753068

Oracle Health Maternity

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00850017753068
Basic UDI-DI: 00850017753OHMLS
Reference: 10000151
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: Oracle Nederland BV
Last updated: 30.07.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom Clarity

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000491
Basic UDI-DI: 038627CLARITY48
Reference: 350-0011
EMDN: Z1204011501
EMDN description: NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Ferring Drug Delivery System

Class IIbMDDOn the marketActive deviceAdministering medicineSingle useSterile

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120293
Basic UDI-DI: B-20385081120293
Reference: ZXG630
EMDN: Z1204021699
EMDN description: PORTABLE MICROINFUSION INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-9H

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120200
Basic UDI-DI: B-20385081120200
Reference: 18916-9H
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Finland
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-6L

Class IIbMDDOn the marketActive deviceMeasuring functionSterile

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120194
Basic UDI-DI: B-20385081120194
Reference: 18916-6L
EMDN: Z120402160101
EMDN description: PORTABLE INSULIN MICROINFUSORS
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-6G

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring functionSterile

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120187
Basic UDI-DI: B-20385081120187
Reference: 18916-6G
EMDN: Z120402160101
EMDN description: PORTABLE INSULIN MICROINFUSORS
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

Part No. 18916-6F, SKT-DET456

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring functionSterile

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120170
Basic UDI-DI: B-20385081120170
Reference: 18916-6F
EMDN: Z120402160101
EMDN description: PORTABLE INSULIN MICROINFUSORS
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-5T

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120163
Basic UDI-DI: B-20385081120163
Reference: 18916-5T
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Denmark
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details