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Mirasol™ DOUBLE+ Platelet Disposable Kit for Treatment in Plasma

Mirasol™ DOUBLE+ Platelet Disposable Kit for Treatment in Plasma

Class IIbMDDOn the marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583106901
Basic UDI-DI: B-05020583106901
Reference: 10690
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 16.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mirasol™ DOUBLE Platelet Disposable Kit for Treatment in Platelet Additive Solution

Mirasol™ DOUBLE Platelet Disposable Kit for Treatment in Platelet Additive Solution

Class IIbMDDOn the marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583105904
Basic UDI-DI: B-05020583105904
Reference: 10590
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 16.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mirasol™ Whole Blood Disposable Kit

Mirasol™ Whole Blood Disposable Kit

Class IIbMDDOn the marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583104600
Basic UDI-DI: B-05020583104600
Reference: 10460
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 16.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mirasol™ Plasma Disposable Kit

Mirasol™ Plasma Disposable Kit

Class IIbMDDOn the marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583103900
Basic UDI-DI: B-05020583103900
Reference: 10390
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 16.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mirasol™ Platelet Disposable Kit for Treatment in Plasma

Mirasol™ Platelet Disposable Kit for Treatment in Plasma

Class IIbMDDOn the marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583100909
Basic UDI-DI: B-05020583100909
Reference: 10090
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 16.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

AV500

Class IIaMDDOn the marketActive device

Manufacturer: AccuVein Inc
Manufacturer SRN: US-MF-000013817
UDI-DI: 00850019808018
Basic UDI-DI: B-00850019808018
Reference: AV500
EMDN: Z120499
EMDN description: GENERAL MEDICINE INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

MEDICAL80

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Log 80 srl
Manufacturer SRN: IT-MF-000037731
UDI-DI: 08053687850019
Basic UDI-DI: 805368785MEDICAL80KM
Reference: MEDICAL80
EMDN: Z12040292
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:00

Manufacturer products View details

TTPRO

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Biomedical S.r.l.
Manufacturer SRN: IT-MF-000027821
UDI-DI: 08053670919235
Basic UDI-DI: 805367091TTPROM9
Reference: TTP1430CD-CM
EMDN: Z1204021580
EMDN description: MULTI-DISTRICT ONCOLOGICAL THERAPY INSTRUMENTS (EXCLUDING RADIOTHERAPY) - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:00

Manufacturer products View details

SIBIONICS GS3-R Continuous Glucose Monitoring System

GS3

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Shenzhen SiSensing Co., Ltd.
Manufacturer SRN: CN-MF-000017945
UDI-DI: 06972831643807
Basic UDI-DI: 697283164CGMGS3LQ
Reference: GS3-R
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Portable (Ultrasonic) Nebulizer

Portable (Ultrasonic) Nebulizer

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Dongguan SIMZO Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000015642
UDI-DI: 06959989130007
Basic UDI-DI: 69599891XZNEB0001KC
Reference: NBM-1
EMDN: Z12040210
EMDN description: ULTRASONIC NEBULISERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Accident Blanket

Thermal Accident Blanket

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ningbo Greetmed Medical Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000009634
UDI-DI: 06958627550252
Basic UDI-DI: 69586275GT084-200XS
Reference: GT084-200A
EMDN: Z12040208
EMDN description: BODY THERMOREGULATION EQUIPMENT
First on market country: Portugal
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoMen® iCan

i3, o3

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175004010
Basic UDI-DI: 6934175005A0001PM
Reference: N/A
EMDN: Z1204011502
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 10:30

Manufacturer products Authorised representative products Authorised representative actors View details

Android: V01; iOS: V01

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175001330
Basic UDI-DI: 6934175005A0002PP
Reference: N/A
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 10:30

Manufacturer products Authorised representative products Authorised representative actors View details

NeoGen 5mm Nozzle

NeoGen Nozzle

Class IMDR 2017/745On the marketActive device

Manufacturer: Energist
Manufacturer SRN: GB-MF-000021765
UDI-DI: 15060440520195
Basic UDI-DI: 506044052NeoGen-NZ-001R8
Reference: 930-003
EMDN: Z12040203
EMDN description: DERMAL REGENERATION EQUIPMENT
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 16.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

UV Tactus B

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle use

Manufacturer: SCI Health, UAB
Manufacturer SRN: LT-MF-000040441
UDI-DI: 04779053970016
Basic UDI-DI: 477905397UVTactusQ8
Reference: UV Tactus B
EMDN: Z12040202
EMDN description: PHOTOTHERAPY EQUIPMENT
First on market country: Lithuania
Authorised representative: -
Last updated: 16.07.2026 09:36

Manufacturer products View details

SilentCloud - DiGA (iOS)

SilentCloud

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Aureliym GmbH
Manufacturer SRN: DE-MF-000013571
UDI-DI: 04260768760110
Basic UDI-DI: 426076876UTMSL7
Reference: 011
EMDN: Z12040192
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:20

Manufacturer products View details

Fastening elements and shelves

Class IMDR 2017/745On the marketDirect marking

Manufacturer: provita medical gmbh & co. kg
Manufacturer SRN: DE-MF-000005332
UDI-DI: 04260661452877
Basic UDI-DI: 42601239307JG
Reference: 142485
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:20

Manufacturer products View details

Classic Cart 660 VA / ELG

Classic Cart 660 VA; Classic Cart 660 VA / ELG; Classic Cart 1000 VA; Classic Cart 1000 VA / ELG Classic Cart 1600 VA; Classic Cart 1600 VA / ELG

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Noratel Germany AG
Manufacturer SRN: DE-MF-000024544
UDI-DI: 04260502941232
Basic UDI-DI: 426050294ClassicCartQZ
Reference: Customer specified product
EMDN: Z120499
EMDN description: GENERAL MEDICINE INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:19

Manufacturer products View details

Cable and hose holder

Class IMDR 2017/745On the marketDirect marking

Manufacturer: provita medical gmbh & co. kg
Manufacturer SRN: DE-MF-000005332
UDI-DI: 04260123937027
Basic UDI-DI: 42601239323JE
Reference: 216188
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:16

Manufacturer products View details

Ceiling rail systems + accessories

Class IMDR 2017/745On the marketDirect marking

Manufacturer: provita medical gmbh & co. kg
Manufacturer SRN: DE-MF-000005332
UDI-DI: 04260123935610
Basic UDI-DI: 42601239312J9
Reference: 107349
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:16

Manufacturer products View details