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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

Omnipod Insulin Management System

18916-5S

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120156
Basic UDI-DI: B-20385081120156
Reference: 18916-5S
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Austria
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

18916-5N

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120149
Basic UDI-DI: B-20385081120149
Reference: 18916-5N
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Sweden
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

18916-5M

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120132
Basic UDI-DI: B-20385081120132
Reference: 18916-5M
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Norway
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-5K

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120125
Basic UDI-DI: B-20385081120125
Reference: 18916-5K
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Italy
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring functionSingle useSterile

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120118
Basic UDI-DI: B-20385081120118
Reference: NLT450
EMDN: Z120402160103
EMDN description: PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-5F

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120095
Basic UDI-DI: B-20385081120095
Reference: 18916-5F
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Germany
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

19191

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring functionSingle useSterile

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120033
Basic UDI-DI: B-20385081120033
Reference: ZXP425
EMDN: Z120402160101
EMDN description: PORTABLE INSULIN MICROINFUSORS
First on market country: Netherlands
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-5E

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120088
Basic UDI-DI: B-20385081120088
Reference: 18916-5E
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: Germany
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Omnipod Insulin Management System

18916-5D

Class IIbMDDOn the marketActive deviceAdministering medicineMeasuring function

Manufacturer: Insulet Corporation
Manufacturer SRN: US-MF-000007948
UDI-DI: 20385081120071
Basic UDI-DI: B-20385081120071
Reference: 18916-5D
EMDN: Z120402160102
EMDN description: PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER
First on market country: France
Authorised representative: Insulet Netherlands B.V.
Last updated: 30.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Abdomen-Sensor komplett

Respiratory Effort Sensor

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978601140
Basic UDI-DI: 42519786030022D
Reference: 925380
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 14:20

Manufacturer products View details

Thorax-Sensor komplett

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Dr. Fenyves und Gut Deutschland GmbH
Manufacturer SRN: DE-MF-000005715
UDI-DI: 04251978600112
Basic UDI-DI: 42519786030022D
Reference: 929140
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 14:20

Manufacturer products View details