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

Last updated

15.10.2026 07:28

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125 device results listed.

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i-Smart Electrolyte Quality Control

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IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712905730
Basic UDI-DI: 8806712POCEQC001HW
Reference: POCEQC001
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

mylife Aveo Glucose Control Solutions

GCD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005805
Basic UDI-DI: 8806712BGMCS007VM
Reference: 700026299
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Glucose Control Solutions

GCD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005799
Basic UDI-DI: 8806712BGMCS007VM
Reference: 700026278
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Glucose Control Solutions

GCD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005782
Basic UDI-DI: 8806712BGMCS007VM
Reference: 700026276
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Test Strips

GSD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005744
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026226
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Test Strips

GSD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005720
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026225
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Test Strips

GSD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005713
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026283
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Test Strips

GSD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005706
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026282
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Test Strips

GSD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005690
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026298
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Test Strips

GSD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005683
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026227
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Meter

GM02AAA

IVD Class CIVDR 2017/746On the marketInstrumentProfessional testingSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005676
Basic UDI-DI: 8806712BGMME006VX
Reference: 700026393
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Meter

GM02AAA

IVD Class CIVDR 2017/746On the marketInstrumentProfessional testingSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005652
Basic UDI-DI: 8806712BGMME006VX
Reference: 700026274
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005638
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026279
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005621
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026280
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005607
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026281
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005584
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026203
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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Class IIbMDR 2017/745On the marketActive device

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712009612
Basic UDI-DI: 8806712CGMDM001UV
Reference: HS-FE-51
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

CareSens Air Receiver

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Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712010298
Basic UDI-DI: 8806712CGMR001T5
Reference: CGM-R-001
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

CareSens Air Receiver

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Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712010304
Basic UDI-DI: 8806712CGMR001T5
Reference: CGM-R-001
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

CareSens Air Receiver

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Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712010335
Basic UDI-DI: 8806712CGMR001T5
Reference: CGM-R-001
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details