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SMARTSIGNS

SC300

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968040190
Basic UDI-DI: 5060693520372WF
Reference: SC1200 12H
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: -
Last updated: 16.07.2026 09:46

Manufacturer products View details

SMARTSIGNS

ACC-VSM-213

Class IMDR 2017/745On the marketActive device

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968030245
Basic UDI-DI: 5060693520464WM
Reference: ACC-VSM-215
EMDN: Z1203020282
EMDN description: MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: -
Last updated: 16.07.2026 09:46

Manufacturer products View details

Unit Connection Cable, 1M YS-107P1

General-purpose multi-parameter bedside monitor

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921112489
Basic UDI-DI: 4931921MD10004BD
Reference: YS-107P1
EMDN: Z1203020285
EMDN description: MULTI-PARAMETER MONITORS - CONSUMABLES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

Multigas Unit I/F

Measuring and Monitoring Device for Vital Signs

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Fukuda Denshi Co., Ltd.
Manufacturer SRN: JP-MF-000008253
UDI-DI: 04538612909276
Basic UDI-DI: 4538612020009M
Reference: MGU-801P
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

PB700/800 serial interface cable

Accessories for Measuring and Monitoring Device for Vital Signs

Class IMDR 2017/745On the market

Manufacturer: Fukuda Denshi Co., Ltd.
Manufacturer SRN: JP-MF-000008253
UDI-DI: 04538612054167
Basic UDI-DI: 4538612020019P
Reference: CJ-403RI-70PB
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

HomeSleepTest audio with data contract

HomeSleepTest

Class IIaMDR 2017/745On the market

Manufacturer: SOMNOmedics AG
Manufacturer SRN: DE-PR-000042026
UDI-DI: 04250413406623
Basic UDI-DI: 42504134HomeSleepTestYC
Reference: HSTA102
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 08:57

Manufacturer products View details

Adt/Pedi Intub CO2 Line LTerm

Microstream Advanced

Class IMDR 2017/745On the marketSingle use

Manufacturer: Philips Medical Systems
Manufacturer SRN: US-MF-000002321
UDI-DI: 20884838091836
Basic UDI-DI: 0884838BM547TD
Reference: 989803204521
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

Avalon CL Fetal & Maternal Patch

Class IMDR 2017/745On the marketSingle use

Manufacturer: Philips Medical Systems
Manufacturer SRN: US-MF-000002321
UDI-DI: 20884838059324
Basic UDI-DI: 0884838BM785TX
Reference: 989803196341
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

SOLID GEL TAB ELECTRODE, RESTING ECG

Electrocardiographic Electrodes Cardinal

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Philips Medical Systems
Manufacturer SRN: US-MF-000002321
UDI-DI: 20884838000852
Basic UDI-DI: 0884838BM532SY
Reference: 13943B
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: -
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

Single Patch ECG Electrodes (25)

Single use Electrocardiographic Electro

Class IMDR 2017/745On the marketSingle use

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 10884838101927
Basic UDI-DI: 0884838BM454T5
Reference: 989803179031
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

Adult SpO2 Clip

Reusable SpO2 Clips and Single use Grips

Class IMDR 2017/745On the market

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 10884838100968
Basic UDI-DI: 0884838BM453T3
Reference: 989803166531
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

Kit, Sample, Agents, 3160

Single Use Gas Sampling Line

Class IMDR 2017/745On the marketSingle use

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 00884838109919
Basic UDI-DI: 0884838BM860TL
Reference: 94018
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Gating Interface

Reusable Gating Cables

Class IMDR 2017/745On the market

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 00884838103672
Basic UDI-DI: 0884838BM458TD
Reference: 989803195521
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Short Neonatal ECG 2.0 Cable AAMI

Reusable Electrocardiographic Leads

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 00884838102347
Basic UDI-DI: 0884838BM455T7
Reference: 9222
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Efficia Cardiac Output Module

Cardiac Output Module

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838101913
Basic UDI-DI: 0884838BM568TM
Reference: 863387
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 07:22

Manufacturer products View details

Infant NBP Cuff

Non-Invasive Blood Pressure Cuffs

Class IMDR 2017/745On the market

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 00884838101289
Basic UDI-DI: 0884838BM456T9
Reference: 989803182611
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Printer Kit, USB

Printer and Paper Chart Recorder

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: Invivo, a division of Philips Medical Systems
Manufacturer SRN: US-MF-000002177
UDI-DI: 00884838093928
Basic UDI-DI: 0884838BM461T2
Reference: 989803205011
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: Philips Medizin Systeme Böblingen GmbH
Last updated: 16.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

IntelliVue Active Display AD75

AD75/AD85 Active Displays

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838088009
Basic UDI-DI: 0884838BM571TA
Reference: 867130
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:20

Manufacturer products View details

Flexible Module Server FMX-4

IntelliVue Module Racks

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838086982
Basic UDI-DI: 0884838BM596TS
Reference: 866468
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:20

Manufacturer products View details

IntelliVue Dock

Class IIbMDR 2017/745On the market

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838085244
Basic UDI-DI: 0884838BM538TC
Reference: 867043
EMDN: Z1203020299
EMDN description: MULTI–PARAMETER MONITORS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:20

Manufacturer products View details