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Snuggle Warm Adult Full Body Convective Warming Blanket

Snuggle Warm Patient Warming Blankets

Class IMDR 2017/745On the marketSingle use

Manufacturer: ICU Medical, Inc.
Manufacturer SRN: US-MF-000002566
UDI-DI: 10610586043321
Basic UDI-DI: 0610586M0079DK
Reference: SWU-2001
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Netherlands
Authorised representative: ICU Medical BV
Last updated: 16.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

t:slim X2 Insulin Pump with Control-IQ+ technology

t:slim X2 Insulin Pump

Class IIIMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Tandem Diabetes Care, Inc.
Manufacturer SRN: US-MF-000031791
UDI-DI: 00389152694610
Basic UDI-DI: 0389152TF00098599U
Reference: 1016946
EMDN: Z120402160103
EMDN description: PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS
First on market country: Finland
Safety summary (SSCP/SSP): REC-0022129 · Rev. G
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

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

Tandem Mobi 2 mL Cartridge

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Tandem Diabetes Care, Inc.
Manufacturer SRN: US-MF-000031791
UDI-DI: 00389152001005
Basic UDI-DI: 0389152TF0009858CHN
Reference: 1015212
EMDN: Z1204021685
EMDN description: PORTABLE MICROINFUSION INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

00386270005342

CGM Informed Therapy Adjustment

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005342
Basic UDI-DI: 038627DEXBASAL64
Reference: SW14553
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 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

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

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

Hyper Protect-OR

R9900089

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Rand S.p.A.
Manufacturer SRN: IT-MF-000013507
UDI-DI: +M640R99000891001
Basic UDI-DI: ++M640PROTECTOR5U
Reference: R9900089
EMDN: Z1204021585
EMDN description: MULTI-DISTRICT ONCOLOGICAL THERAPY INSTRUMENTS (EXCLUDING RADIOTHERAPY) - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:52

Manufacturer products View details

Hang&Go HT Basic

R9900088

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Rand S.p.A.
Manufacturer SRN: IT-MF-000013507
UDI-DI: +M640R99000881001
Basic UDI-DI: ++M640HIPEC8R
Reference: R9900088
EMDN: Z1204021585
EMDN description: MULTI-DISTRICT ONCOLOGICAL THERAPY INSTRUMENTS (EXCLUDING RADIOTHERAPY) - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:52

Manufacturer products View details

ILP HT

R9900086

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Rand S.p.A.
Manufacturer SRN: IT-MF-000013507
UDI-DI: +M640R99000861001
Basic UDI-DI: ++M640ILPX4
Reference: R9900086
EMDN: Z1204021585
EMDN description: MULTI-DISTRICT ONCOLOGICAL THERAPY INSTRUMENTS (EXCLUDING RADIOTHERAPY) - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:52

Manufacturer products View details

Hang&Go HT

Hang&Go

Class IIbMDR 2017/745On the marketSterile

Manufacturer: Rand S.p.A.
Manufacturer SRN: IT-PR-000013538
UDI-DI: +M640R99000671001
Basic UDI-DI: ++M640HANGGOKITHK
Reference: R9900067
EMDN: Z1204021585
EMDN description: MULTI-DISTRICT ONCOLOGICAL THERAPY INSTRUMENTS (EXCLUDING RADIOTHERAPY) - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 21:52

Manufacturer products View details

Performer 3

R5100075

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Rand S.p.A.
Manufacturer SRN: IT-MF-000013507
UDI-DI: +M640R51000751001
Basic UDI-DI: ++M640PERFORMER3D9
Reference: R5100075
EMDN: Z1204021501
EMDN description: MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:52

Manufacturer products View details

MED-UV EPL 308

1091

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GME German Medical Engineering GmbH
Manufacturer SRN: DE-MF-000009384
UDI-DI: +B12510910S
Basic UDI-DI: ++B1251090UM
Reference: 1091
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:47

Manufacturer products View details

THERAFOX PRO Medizinische Scores

THERAFOX PRO Medical Scores

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ifap Service-Institut für Ärzte und Apotheker GmbH
Manufacturer SRN: DE-MF-000006908
UDI-DI: 1311682TFMEDSCORES5.181
Basic UDI-DI: PP11682TFPROMEDSCORESR565
Reference: R5.1
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:39

Manufacturer products View details

THERAFOX PRO AMTS

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ifap Service-Institut für Ärzte und Apotheker GmbH
Manufacturer SRN: DE-MF-000006908
UDI-DI: 1311682TFAMTS5.095
Basic UDI-DI: PP11682THERAFOXPRO60
Reference: THERAFOX PRO AMTS ab R5.0
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:39

Manufacturer products View details

MMI-AMTS-Service

Software für die Arzneimitteltherapiesicherheit

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Vidal MMI Germany GmbH
Manufacturer SRN: DE-MF-000018852
UDI-DI: 111753218466
Basic UDI-DI: PP11862AMTS.2A.1722264
Reference: Version 1.1
EMDN: Z12040282
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:35

Manufacturer products View details