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05060434422040

QPF2

Class IMDR 2017/745On the market

Manufacturer: Spectrum Medical Ltd
Manufacturer SRN: GB-MF-000033594
UDI-DI: 05060434422040
Basic UDI-DI: 506043442QPFE7
Reference: 51-000025-01
EMDN: Z12050280
EMDN description: EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Spectrum Medical S.r.l.
Last updated: 31.07.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

05060434420992

Hand Crank Assembly - 4 inch

Class IMDR 2017/745On the marketAdministering medicine

Manufacturer: Spectrum Medical Ltd
Manufacturer SRN: GB-MF-000033594
UDI-DI: 05060434420992
Basic UDI-DI: 506043442QRPHC7R
Reference: 43-000954-00
EMDN: Z12050280
EMDN description: EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Spectrum Medical S.r.l.
Last updated: 31.07.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

LiDCO Injectate Kit

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: LiDCO Ltd
Manufacturer SRN: GB-MF-000008036
UDI-DI: 05060110521791
Basic UDI-DI: 506011052000Z7T5C01V003CR
Reference: CM 50-EUW-01
EMDN: Z12050785
EMDN description: INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - CONSUMABLES
First on market country: Netherlands
Authorised representative: LiDCO Netherlands B.V.
Last updated: 31.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flow Regulator

CM 33

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: LiDCO Ltd
Manufacturer SRN: GB-MF-000008036
UDI-DI: 05060110520800
Basic UDI-DI: 506011052000Z7T5C01V005CV
Reference: CM 33
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: LiDCO Netherlands B.V.
Last updated: 31.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

LiDCO Sensor

CM 10 PAS

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: LiDCO Ltd
Manufacturer SRN: GB-MF-000008036
UDI-DI: 05060110520107
Basic UDI-DI: 506011052000Z7T1C01V000A7
Reference: CM 10 PAS
EMDN: Z12050785
EMDN description: INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - CONSUMABLES
First on market country: Netherlands
Authorised representative: LiDCO Netherlands B.V.
Last updated: 31.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD ACCESSORY KIT A YD-121D

Electrocardiograph, professional, multichannel

Class IMDR 2017/745On the market

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921120491
Basic UDI-DI: 4931921MD10015BJ
Reference: YD-121D
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Multichannel Electrocardiograph

PHS-U10

Class IIaMDR 2017/745On the market

Manufacturer: PhysioSign Hong Kong Medical Limited
Manufacturer SRN: CN-MF-000041466
UDI-DI: 04897139610011
Basic UDI-DI: 489713961001L4
Reference: PHS-U10
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: Everbiz GmbH
Last updated: 31.07.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx

Rooti Rx System

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle use

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370122
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP01-50
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx

Rooti Rx Patch

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370146
Basic UDI-DI: 471987337RootiRxPatchTH8
Reference: RXAP02-50
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx

Rooti Rx System

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370115
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP01
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

PCA 300

QTERD100

Class IIaMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: QT Medical, Inc.
Manufacturer SRN: US-MF-000014384
UDI-DI: 04719872981756
Basic UDI-DI: 471987298002QTERD001WH
Reference: QTERD100
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

QT ECG APP

QT ECG App

Class IIaMDR 2017/745Not intended for EU marketMeasuring function

Manufacturer: QT Medical, Inc.
Manufacturer SRN: US-MF-000014384
UDI-DI: 04719872981084
Basic UDI-DI: 471987298QTECGAPPQE
Reference: Android
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370153
Basic UDI-DI: 471987337RootiCare8E
Reference: RootiCare
EMDN: Z12050892
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx

Rooti Rx Patch

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370139
Basic UDI-DI: 471987337RootiRxPatchTH8
Reference: RXAP02
EMDN: Z12050880
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Rooti Rx

Rooti Rx System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370092
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP02, RXAP03, RXMD01, RXMD02, ASCD01
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

PCA 500

QTERD100

Class IIaMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: QT Medical, Inc.
Manufacturer SRN: US-MF-000014384
UDI-DI: 04719872981503
Basic UDI-DI: 471987298002QTERD001WH
Reference: QTERD100
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

QT ECG APP

QT ECG App

Class IIaMDR 2017/745Not intended for EU marketMeasuring function

Manufacturer: QT Medical, Inc.
Manufacturer SRN: US-MF-000014384
UDI-DI: 04719872981060
Basic UDI-DI: 471987298QTECGAPPQE
Reference: iOS
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sphygmomanometer and Sphygmograph Data Management System VSS-50

Sphygmomanometer and Sphygmograph

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Fukuda Denshi Co., Ltd.
Manufacturer SRN: JP-MF-000008253
UDI-DI: 04538612912252
Basic UDI-DI: 4538612011009K
Reference: VSS-50
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Connection Cable

Accessories for Sphygmomanometer and Sphygmograph

Class IMDR 2017/745On the market

Manufacturer: Fukuda Denshi Co., Ltd.
Manufacturer SRN: JP-MF-000008253
UDI-DI: 04538612311628
Basic UDI-DI: 4538612011019M
Reference: CJV-03SS2.5
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

ECG AMP Module

Electrocardiograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Fukuda Denshi Co., Ltd.
Manufacturer SRN: JP-MF-000008253
UDI-DI: 04538612100970
Basic UDI-DI: 4538612010009E
Reference: EE-50
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details