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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

07.07.2026 02:24

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Device

2695495

Actor

47325

Certificate

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Active filter:Manufacturer SRN:CN-MF-000016483

80 device results listed.

Page 3 / 4

Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081203
Basic UDI-DI
697091208AECGGJ
Reference
BIP-03C
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081197
Basic UDI-DI
697091208AECGGJ
Reference
BIP-03B
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081180
Basic UDI-DI
697091208AECGGJ
Reference
BIP-03A
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Wearable ECG Sensor

PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F

Class IMDR 2017/745On the marketSingle use
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081111
Basic UDI-DI
697091208PS2G
Reference
PS-B3C
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Wearable ECG Sensor

PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F

Class IMDR 2017/745On the marketSingle use
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081104
Basic UDI-DI
697091208PS2G
Reference
PS-B3B
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Wearable ECG Sensor

PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F

Class IMDR 2017/745On the marketSingle use
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081098
Basic UDI-DI
697091208PS2G
Reference
PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
ECG Patient Cable

PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49

Class IMDR 2017/745On the market
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081081
Basic UDI-DI
697091208PL22
Reference
PL-M3B
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
ECG Patient Cable

PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49

Class IMDR 2017/745On the market
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081074
Basic UDI-DI
697091208PL22
Reference
PL-M3A
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
ECG Patient Cable

PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49

Class IMDR 2017/745On the market
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081067
Basic UDI-DI
697091208PL22
Reference
PL-B3B
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
ECG Patient Cable

PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49

Class IMDR 2017/745On the market
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081050
Basic UDI-DI
697091208PL22
Reference
PL-B3A
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
ECG Patient Cable

PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49

Class IMDR 2017/745On the market
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081043
Basic UDI-DI
697091208PL22
Reference
PL-U3B
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Austria
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
ECG Patient Cable

PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49

Class IMDR 2017/745On the market
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912081036
Basic UDI-DI
697091208PL22
Reference
PL-U3A, PL-U3B, PL-B3A, PL-B3B, PL-M3A, PL-M3B
EMDN
Z12050485
EMDN description
HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080848
Basic UDI-DI
697091208AECGGJ
Reference
BI9900
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080831
Basic UDI-DI
697091208AECGGJ
Reference
BI9100
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080824
Basic UDI-DI
697091208AECGGJ
Reference
CSC 6612
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080817
Basic UDI-DI
697091208AECGGJ
Reference
EP830-12
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080800
Basic UDI-DI
697091208AECGGJ
Reference
EP830
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080794
Basic UDI-DI
697091208AECGGJ
Reference
EP820-12
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080787
Basic UDI-DI
697091208AECGGJ
Reference
EP820
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30
Holter System

BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReusable
Manufacturer
Biomedical Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000016483
UDI-DI
06970912080770
Basic UDI-DI
697091208AECGGJ
Reference
TRAK-48
EMDN
Z12050403
EMDN description
ECG HOLTER RECORDERS
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
30.06.2026 10:30