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07896436906817

HCG-8060T-GL

Class IIaMDR 2017/745Not intended for EU marketActive device

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 07896436906817
Basic UDI-DI: 789643690681RW
Reference: HCG-8060T-GL
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: -
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 04.08.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

kabel EKG do diagnostyki

ECG diagnostic cables

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212625057
Basic UDI-DI: 5903002221075J
Reference: KB-10/0-H/ep-Ad/L-70/90/250-IEC
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:54

Manufacturer products View details

kabel EKG do monitorowania

ECG monitoring cables

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212624432
Basic UDI-DI: 5903002221085L
Reference: KM-4/0-12o/L-250-44
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:54

Manufacturer products View details

przewód dołączeniowy

leadwires

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212624111
Basic UDI-DI: 59030022211057
Reference: PD-K-8/L-150-21
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:54

Manufacturer products View details

adaptery EKG

ECG adapters

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212628409
Basic UDI-DI: 59030022211159
Reference: WB-5 732
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:50

Manufacturer products View details

Kabel EKG do badań holterowskich

Holter ECG cables

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212624456
Basic UDI-DI: 5903002221095N
Reference: KH-5/0-H/0-LA10a/L-70/90/250-51
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:49

Manufacturer products View details

kabel EKG do monitorowania

ECG monitoring cables

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212624395
Basic UDI-DI: 5903002221085L
Reference: KB-3/i-M/1-Rp/L-60/200-32
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:49

Manufacturer products View details

przewód dołączeniowy

leadwires

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05908212624050
Basic UDI-DI: 59030022211057
Reference: PD-5Hb/0-0e2/L-70-201
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:49

Manufacturer products View details

Toe Cuff

Accessories for Sphygmomanometer and Sphygmograph

Class IMDR 2017/745On the market

Manufacturer: Fukuda Denshi Co., Ltd.
Manufacturer SRN: JP-MF-000008253
UDI-DI: 04538612312175
Basic UDI-DI: 4538612011019M
Reference: CUF-250M-T
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

ZONCARE

iMAC 1800，iMAC 1800pro

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Wuhan Zoncare Bio-medical Electronics Co.,Ltd
Manufacturer SRN: CN-MF-000010439
UDI-DI: 06956913482171
Basic UDI-DI: B-06956913482171
Reference: /
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Wellkang Ltd
Last updated: 03.08.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

H12

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429020823
Basic UDI-DI: B-06945429020823
Reference: H12
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Belgium
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

BeneHeart R12

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904042077
Basic UDI-DI: B-06944904042077
Reference: 123
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

06922649906014

ECG1212

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Beijing M&B Electronic Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000010160
UDI-DI: 06922649906014
Basic UDI-DI: B-06922649906014
Reference: /
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

Awario Application

Class IIaMDDOn the marketActive device

Manufacturer: Heart2Save Oy
Manufacturer SRN: FI-MF-000004794
UDI-DI: 06429810583017
Basic UDI-DI: B-06429810583017
Reference: 2010
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

Awario Analysis Service

Class IIaMDDOn the marketActive device

Manufacturer: Heart2Save Oy
Manufacturer SRN: FI-MF-000004794
UDI-DI: 06429810583000
Basic UDI-DI: B-06429810583000
Reference: 1010
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

Cardiax PC ECG USB

USB

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: IMED Orvosi Berendezéseket Fejlesztő Kft.
Manufacturer SRN: HU-MF-000015964
UDI-DI: 05999862292010
Basic UDI-DI: B-05999862292010
Reference: CRX02
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:25

Manufacturer products View details

ISTEL HR-2000

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581254479
Basic UDI-DI: B-05907581254479
Reference: 8003
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

Manufacturer products View details

ISTEL ECG

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581250693
Basic UDI-DI: B-05907581250693
Reference: 8004
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

Manufacturer products View details

M-TRACE mini

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: M4Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000022164
UDI-DI: 05905358809020
Basic UDI-DI: B-05905358809020
Reference: M-TRACE mini
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:30

Manufacturer products View details

M-TRACE PC

M_TRACE PC

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: M4Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000022164
UDI-DI: 05905358809013
Basic UDI-DI: B-05905358809013
Reference: M-TARCE PC
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:29

Manufacturer products View details