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

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107 device results listed.

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STANDARD™ M10 C. difficile BT

M10-CBT-01

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723117
Basic UDI-DI: 88001117IPBA01MA05WV
Reference: 11CDC20A
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 MTB-RIF/INH

M10-MTB-02

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722929
Basic UDI-DI: 88001117IPCA01MA19XT
Reference: M10-MTB-02/11MTB30A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i pre-Trigger

i-PTR-01

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722691
Basic UDI-DI: 88001117IPAA05IA01WJ
Reference: 16PTR10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Trigger

i-TRG-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722684
Basic UDI-DI: 88001117IPAA06IA01WV
Reference: 16TR10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Wash buffer

i-WBF-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722677
Basic UDI-DI: 88001117IPAA07IA01X8
Reference: 16WB10
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i TSH

i-TSH-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722035
Basic UDI-DI: 88001117IPBA01IA12VW
Reference: 16TSH10D
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ LMS (Lipid Management Software)

02LMS10

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724831
Basic UDI-DI: 88001117IAAA01PA14L7
Reference: 02LMS10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ DMS (Diabetes Management Software)

01DMS10

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724824
Basic UDI-DI: 88001117IAAA01PA15L9
Reference: 01DMS10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Pic Diabetes Management

99DMS30

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724817
Basic UDI-DI: 88001117IAAA02PA15LL
Reference: 99DMS30
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoNavii® App

G-APP-01

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724800
Basic UDI-DI: 88001117IAAA01PA16LB
Reference: 01APP10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Cleanser

i-CLE-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722660
Basic UDI-DI: 88001117IPAA04IA01W7
Reference: 16CL10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i2000

i2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111720260
Basic UDI-DI: 88001117IPAA01IA02V8
Reference: 16IA200
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i1000

i1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111720253
Basic UDI-DI: 88001117IPAA01IA01V6
Reference: 16IA100
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 STI Sample Pretreatment Kit

M10-STIP-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111719219
Basic UDI-DI: 88001117IPAA01MA12W7
Reference: M10-STIP-01
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Stool Pretreatment kit

M10-STP-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111718557
Basic UDI-DI: 88001117IPAA01MA13W9
Reference: 11PRT20A
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Sputum Pretreatment Kit

M10-SPTP-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111718540
Basic UDI-DI: 88001117IPAA01MA11W5
Reference: M10-SPTP-01/11PRT10A
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Calibration Kit

M10-CAL-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111711350
Basic UDI-DI: 88001117IPAA01MA02W4
Reference: M10-CAL-01/11CAL10H
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ F Calibration Kit

FCAL-10

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111711213
Basic UDI-DI: 88001117IPAA01FA29V7
Reference: 10CAL10
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Module

M10-01S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111706424
Basic UDI-DI: 88001117IPAA01MA01W2
Reference: M10-01M/11M1012
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ d-BLOCK Incubator

90-IC10-01

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111702273
Basic UDI-DI: 88001117IPAA01AA03TJ
Reference: 12INC10
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details