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EUDAMED Device Search

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

Last updated

09.07.2026 14:28

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S

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341390
Basic UDI-DI: B-06971049341390
Reference: S
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

PCECG-500

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341291
Basic UDI-DI: B-06971049341291
Reference: PCECG-500
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

TH12

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341277
Basic UDI-DI: B-06971049341277
Reference: TH12
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

TH3

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341260
Basic UDI-DI: B-06971049341260
Reference: TH3
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1112M

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341178
Basic UDI-DI: B-06971049341178
Reference: ECG-1112M
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Spain
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1112M

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341116
Basic UDI-DI: B-06971049341116
Reference: ECG-1112M
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1112L

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341109
Basic UDI-DI: B-06971049341109
Reference: ECG-1112L
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1112D

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341093
Basic UDI-DI: B-06971049341093
Reference: ECG-1112D
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1112

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341086
Basic UDI-DI: B-06971049341086
Reference: ECG-1112
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103LW(I)

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340287
Basic UDI-DI: B-06971049340287
Reference: ECG-1103LW(I)
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103G(I)

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340256
Basic UDI-DI: B-06971049340256
Reference: ECG-1103G (I)
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1106L

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340201
Basic UDI-DI: B-06971049340201
Reference: ECG-1106L
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1106G

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340195
Basic UDI-DI: B-06971049340195
Reference: ECG-1106G
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103LW

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340188
Basic UDI-DI: B-06971049340188
Reference: ECG-1103LW
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103L

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340171
Basic UDI-DI: B-06971049340171
Reference: ECG-1103L
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103GW

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340164
Basic UDI-DI: B-06971049340164
Reference: ECG-1103GW
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103G

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340157
Basic UDI-DI: B-06971049340157
Reference: ECG-1103G
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

ECG-1103B

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049340140
Basic UDI-DI: B-06971049340140
Reference: ECG-1103B
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

CoCr Sirolimus-eluting Coronary Stent System

Class IIIMDDOn the marketImplantableMedicinal productSingle useSterile

Manufacturer: Lepu Medical Technology (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000001408
UDI-DI: 06936733748824
Basic UDI-DI: B-06936733748824
Reference: LPRPC2208
EMDN: P070402010301
EMDN description: CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS
First on market country: Spain
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

Hemodialysis Equipment

Aide1, Aide1 SE, Aide1 Pro, Aide1 Max, Aide2, Aide2 Pro, Aide3, Aide3 Pro

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GUANGZHOU OCI MEDICAL DEVICES CO., LTD.
Manufacturer SRN: CN-MF-000036303
UDI-DI: 06976533600014
Basic UDI-DI: 69765336000001ZS
Reference: S01020200001
EMDN: Z12090201
EMDN description: HAEMODIALYSIS EQUIPMENT
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details