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Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270001542
Basic UDI-DI: 038627D1+CGMKB
Reference: SW10846
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom API

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000668
Basic UDI-DI: 038627APIUC
Reference: SW13183
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

Texlight 6V1

Class INot specifiedOn the market

Manufacturer: MDB TEXINOV
Manufacturer SRN: FR-MF-000001728
UDI-DI: 03770021816696
Basic UDI-DI: 3770021816TEXTLIGHTU9
Reference: Texlight 6V1
EMDN: Z12040280
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Texlight 4V1

Class INot specifiedOn the market

Manufacturer: MDB TEXINOV
Manufacturer SRN: FR-MF-000001728
UDI-DI: 03770021816672
Basic UDI-DI: 3770021816TEXTLIGHTU9
Reference: Texlight 4V1
EMDN: Z12040280
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Texlight 3V1

Class INot specifiedOn the market

Manufacturer: MDB TEXINOV
Manufacturer SRN: FR-MF-000001728
UDI-DI: 03770021816658
Basic UDI-DI: 3770021816TEXTLIGHTU9
Reference: Texlight 3V1
EMDN: Z12040280
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:58

Manufacturer products View details

LifeGlobal Coda Inline Filter: Purple

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032901
Basic UDI-DI: 0888937TD004ZB
Reference: CIPR-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda Xtra Inline Filter: Green

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032918
Basic UDI-DI: 0888937TD004ZB
Reference: CXGR-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

ORIGIO® Gas Line Filter

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937033915
Basic UDI-DI: 0888937TD004ZB
Reference: ULTRA-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda 2 Incubator Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032871
Basic UDI-DI: 0888937TD004ZB
Reference: C2IU-010-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

LifeGlobal Coda Filter for Incubator Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 00888937032840
Basic UDI-DI: 0888937TD004ZB
Reference: GCIF-001-M
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 15.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

VEOS

51550

Class IMDR 2017/745On the marketActive device

Manufacturer: CANFIELD SCIENTIFIC Inc
Manufacturer SRN: US-MF-000042029
UDI-DI: 00860010618134
Basic UDI-DI: 008600106181VEOS8K
Reference: 51550
EMDN: Z12040108
EMDN description: DERMATOSCOPES
First on market country: Italy
Authorised representative: CANFIELD SCIENTIFIC SRL
Last updated: 15.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Canfield Scientific, Inc.

D2 Dermatoscope

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: CANFIELD SCIENTIFIC Inc
Manufacturer SRN: US-MF-000042029
UDI-DI: 00860010618103
Basic UDI-DI: 008600106D2FQ
Reference: 51400
EMDN: Z12040108
EMDN description: DERMATOSCOPES
First on market country: Italy
Authorised representative: CANFIELD SCIENTIFIC SRL
Last updated: 15.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006937

Obstetrix

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006937
Basic UDI-DI: 00853023006Obstetrix9M
Reference: 1000197
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006920

Melior

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006920
Basic UDI-DI: 00853023006MeliorC4
Reference: 135648
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006739

Oracle Health Media Storage

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006739
Basic UDI-DI: 008530230067OHMS9Q
Reference: 10000496
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006173

Oracle Health Blood Bank

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006173
Basic UDI-DI: 0085302300BBTS6
Reference: 10000128
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

00853023006289

Oracle Health Laboratory Sequence

Class IMDR 2017/745On the marketActive device

Manufacturer: Cerner Corporation
Manufacturer SRN: US-MF-000007215
UDI-DI: 00853023006289
Basic UDI-DI: 00853023006LSRB
Reference: 10000216
EMDN: Z12040182
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Oracle Nederland BV
Last updated: 15.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

t:slim X2 3mL Cartridge with Sterile Syringe and Needle

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: Tandem Diabetes Care, Inc.
Manufacturer SRN: US-PR-000041891
UDI-DI: 00389152000978
Basic UDI-DI: 00389152TF0009858PBC
Reference: 1013858
EMDN: Z1204021685
EMDN description: PORTABLE MICROINFUSION INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:03

Manufacturer products View details

Tandem Mobi System

Class IIIMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Tandem Diabetes Care, Inc.
Manufacturer SRN: US-MF-000031791
UDI-DI: 00389152691213
Basic UDI-DI: 00389152TF0018738ZJ
Reference: 1016912
EMDN: Z120402160103
EMDN description: PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS
First on market country: Netherlands
Safety summary (SSCP/SSP): REC-0022195 · Rev. E
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

10000 mL Waste Bags

R9900111

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Rand S.p.A.
Manufacturer SRN: IT-MF-000013507
UDI-DI: +M640R99001111001
Basic UDI-DI: ++M640WASTEBAGL9
Reference: R9900111
EMDN: Z1204021585
EMDN description: MULTI-DISTRICT ONCOLOGICAL THERAPY INSTRUMENTS (EXCLUDING RADIOTHERAPY) - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 15.07.2026 21:52

Manufacturer products View details