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TREN

Last updated

21.09.2026 00:16

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Device

3108040

Actor

47631

Certificate

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Active filter:EMDN:Z120508

63 device results listed.

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CardioSignal Inside

-

Class IIbNot specifiedOn the marketDirect marking
Manufacturer
Precordior Oy
Manufacturer SRN
FI-MF-000014540
UDI-DI
06430081450083
Basic UDI-DI
643008145CSAFIB3Y
Reference
Android v. 1.0
EMDN
Z12050892
EMDN description
CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Finland
Authorised representative
-
Last updated
11.08.2026 22:58
Manufacturer productsView details
CardioSignal Inside

-

Class IIbNot specifiedOn the marketDirect marking
Manufacturer
Precordior Oy
Manufacturer SRN
FI-MF-000014540
UDI-DI
06430081450076
Basic UDI-DI
643008145CSAFIB3Y
Reference
iOS v. 1.0
EMDN
Z12050892
EMDN description
CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Finland
Authorised representative
-
Last updated
11.08.2026 22:58
Manufacturer productsView details
CardioSignal

-

Class IIbNot specifiedOn the marketDirect marking
Manufacturer
Precordior Oy
Manufacturer SRN
FI-MF-000014540
UDI-DI
06430081450069
Basic UDI-DI
643008145CSAFIB3Y
Reference
Android v. 3.1
EMDN
Z12050892
EMDN description
CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Finland
Authorised representative
-
Last updated
11.08.2026 22:58
Manufacturer productsView details
CardioSignal

CardioSignal

Class IIbMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
Precordior Oy
Manufacturer SRN
FI-MF-000014540
UDI-DI
06430081450052
Basic UDI-DI
643008145CSAFIB3Y
Reference
iOS v. 3.1
EMDN
Z12050892
EMDN description
CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Finland
Authorised representative
-
Last updated
11.08.2026 22:58
Manufacturer productsView details
μCor Heart Failure and Arrhythmia Management System (HFAMS)

μCor Heart Failure and Arrhythmia Management System (HFAMS)

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking
Manufacturer
ZOLL Manufacturing Corporation
Manufacturer SRN
US-MF-000027987
UDI-DI
00855778005555
Basic UDI-DI
0855778005K172510WG
Reference
10A1071
EMDN
Z12050801
EMDN description
COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country
-
Authorised representative
ZOLL International Holding B.V.
Last updated
11.08.2026 21:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MX40 - 2.4

MX40 Patient Wearable Monitor

Class IIbMDDOn the marketActive device
Manufacturer
Philips Medical Systems
Manufacturer SRN
US-MF-000002321
UDI-DI
00884838082243
Basic UDI-DI
B-00884838082243
Reference
865351
EMDN
Z12050803
EMDN description
ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS
First on market country
Austria
Authorised representative
Philips Medizin Systeme Böblingen GmbH
Last updated
05.08.2026 01:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
μCor Heart Failure and Arrhythmia Management System (HFAMS)

μCor Heart Failure and Arrhythmia Management System (HFAMS)

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking
Manufacturer
ZOLL Manufacturing Corporation
Manufacturer SRN
US-MF-000027987
UDI-DI
00855778005562
Basic UDI-DI
0855778005K172510WG
Reference
10A1072
EMDN
Z12050801
EMDN description
COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country
-
Authorised representative
ZOLL International Holding B.V.
Last updated
04.08.2026 21:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
μCor Heart Failure and Arrhythmia Management System (HFAMS)

-

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking
Manufacturer
ZOLL Manufacturing Corporation
Manufacturer SRN
US-MF-000027987
UDI-DI
00855778005609
Basic UDI-DI
0855778005K172510WG
Reference
10A1073
EMDN
Z12050801
EMDN description
COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country
-
Authorised representative
ZOLL International Holding B.V.
Last updated
03.08.2026 22:50
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
μCor Heart Failure and Arrhythmia Management System (HFAMS)

-

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking
Manufacturer
ZOLL Manufacturing Corporation
Manufacturer SRN
US-MF-000027987
UDI-DI
00855778005616
Basic UDI-DI
0855778005K172510WG
Reference
10A1067
EMDN
Z12050801
EMDN description
COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country
-
Authorised representative
ZOLL International Holding B.V.
Last updated
03.08.2026 22:50
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MX40 - WLAN

MX40 Patient Wearable Monitor

Class IIbMDDOn the marketActive device
Manufacturer
Philips Medical Systems
Manufacturer SRN
US-MF-000002321
UDI-DI
00884838030350
Basic UDI-DI
B-00884838030350
Reference
865352
EMDN
Z12050803
EMDN description
ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS
First on market country
Austria
Authorised representative
Philips Medizin Systeme Böblingen GmbH
Last updated
01.08.2026 20:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SEERLINQ HeartCore

SEERLINQ HeartCore

Class IIbMDR 2017/745On the marketActive deviceDirect marking
Manufacturer
Seerlinq s.r.o.
Manufacturer SRN
SK-MF-000040803
UDI-DI
08588009909002
Basic UDI-DI
8588009909SeerlinqHCWA
Reference
1
EMDN
Z12050892
EMDN description
CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Slovakia
Authorised representative
-
Last updated
31.07.2026 23:12
Manufacturer productsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
ECG, Respiration and SpO2 Transmitter, model LX-7230N, LX-7230KM

Measuring and Monitoring Equipment for Vital Signs

Class IIbMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
Fukuda Denshi Co., Ltd.
Manufacturer SRN
JP-MF-000008253
UDI-DI
04538612907739
Basic UDI-DI
4538612022009X
Reference
LX-7230N
EMDN
Z12050803
EMDN description
ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS
First on market country
Italy
Authorised representative
Emergo Europe B.V.
Last updated
31.07.2026 05:51
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Disposable Portable Case

Accessories for Measuring and Monitoring Equipment for Vital Signs

Class IMDR 2017/745On the market
Manufacturer
Fukuda Denshi Co., Ltd.
Manufacturer SRN
JP-MF-000008253
UDI-DI
04538612054181
Basic UDI-DI
4538612022019Z
Reference
ABT-720D
EMDN
Z12050803
EMDN description
ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS
First on market country
Italy
Authorised representative
Emergo Europe B.V.
Last updated
31.07.2026 05:51
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details