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Active filter:Manufacturer SRN:KR-MF-000043626

9 device results listed.

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GenBody KET

DKET010

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700918
Basic UDI-DI: B-08800076700918
Reference: DKET010
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

HelicoSign Dry

HPYD050

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700451
Basic UDI-DI: B-08800076700451
Reference: HPYD050
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

08800076701205

HMCT001

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701205
Basic UDI-DI: 88000767HMCT001JN
Reference: HMCT001
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Hemonitor H1 microcuvette

HMAC050

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701199
Basic UDI-DI: 88000767HMAC050EN
Reference: HMAC050
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Hemonitor H1

HMGA101

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701007
Basic UDI-DI: 88000767HMGA101G2
Reference: HMGA101
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

ConfiGlu G1 Glucose Control solution 3

BGC003

IVD Class CIVDR 2017/746On the marketReagentSelf testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701328
Basic UDI-DI: 88000767BGC0038K
Reference: BGC003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): GB-SSP-207 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

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

ConfiGlu G1 Glucose Control solution 2

BGC002

IVD Class CIVDR 2017/746On the marketReagentSelf testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701106
Basic UDI-DI: 88000767BGC0028H
Reference: BGC002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): GB-SSP-207 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

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

ConfiGlu G1 Blood Glucose Meter Set

BGMGS001

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentSelf testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700833
Basic UDI-DI: 88000767BGMGS001PX
Reference: BGMGS001
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): GB-SSP-207 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

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

ConfiGlu G1 Blood Glucose Test Strip

BGSG001

IVD Class CIVDR 2017/746On the marketReagentSelf testingSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700819
Basic UDI-DI: 88000767BGSG001FP
Reference: BGSG001
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): GB-SSP-207 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

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