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Visensia V4.2.1.50

011-0700

Class IIaMDDOn the marketActive device

Manufacturer: OBS Medical Ltd
Manufacturer SRN: GB-MF-000028311
UDI-DI: 5060457930102
Basic UDI-DI: B-5060457930102
Reference: 011-0700
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Austria
Authorised representative: AF Pharma Service Europe SL
Last updated: 17.07.2026 02:13

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

CMS9000

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100515
Basic UDI-DI: B-06945040100515
Reference: CMS9000
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: France
Authorised representative: Prolinx GmbH
Last updated: 16.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

CMS7000

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100058
Basic UDI-DI: B-06945040100058
Reference: CMS7000
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Poland
Authorised representative: Prolinx GmbH
Last updated: 16.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

CMS8000

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100034
Basic UDI-DI: B-06945040100034
Reference: CMS8000
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Poland
Authorised representative: Prolinx GmbH
Last updated: 16.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

CMS6000

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100027
Basic UDI-DI: B-06945040100027
Reference: CMS6000
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Netherlands
Authorised representative: Prolinx GmbH
Last updated: 16.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

PM12B/PM12D

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Le Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000007686
UDI-DI: 06975070970024
Basic UDI-DI: 6975070970031B3
Reference: PM12B
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:14

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Witleaf Medical Electronics Co., Ltd
Manufacturer SRN: CN-MF-000040494
UDI-DI: 06970005394012
Basic UDI-DI: 697000539PMWTEL63S21ES
Reference: W12A
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: France
Authorised representative: Zug Medical Systems
Last updated: 16.07.2026 10:52

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

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

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

IntelliVue Patient Monitor MX850

MX750/850

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838070790
Basic UDI-DI: 0884838BM591TG
Reference: 866470
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:19

Manufacturer products View details

G30E

G-Series patient monitor, Model is G30E

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Goldway (Shenzhen) Industrial Inc.
Manufacturer SRN: CN-MF-000003921
UDI-DI: 00884838065055
Basic UDI-DI: 0884838BM475TD
Reference: 866480
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Portugal
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

IntelliVue Patient Monitor MX400

MX400-550

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838038752
Basic UDI-DI: 0884838BM589TV
Reference: 866060
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:19

Manufacturer products View details

Patient Monitor 6100

Patient Monitor 6000 Series

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Philips Medizin Systeme Böblingen GmbH
Manufacturer SRN: DE-MF-000006026
UDI-DI: 00884838107786
Basic UDI-DI: 0884838BM1697NG
Reference: 867311
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 07:11

Manufacturer products View details

04048675723684

Vista 300

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shanghai Dräger Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000012737
UDI-DI: 04048675723684
Basic UDI-DI: 040486754307007VK19Z000HW
Reference: 2601966
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Germany
Authorised representative: Drägerwerk AG & Co. KGaA
Last updated: 16.07.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

UbiqVue 1AX Wearable Biosensor

UB1550

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: LifeSignals, Inc.
Manufacturer SRN: US-MF-000033437
UDI-DI: ++B353UB1550KS
Basic UDI-DI: ++B353UX1550TC
Reference: UB1550
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Ireland
Authorised representative: Renew Health Ltd.
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

B105M Patient Monitor

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490223
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-103
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

B125P Patient Monitor

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490230
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-102
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

B125M Patient Monitor

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490247
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-104
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details