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EUDAMED Device Search

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

Last updated

05.07.2026 16:34

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HIM-2

Class IMDR 2017/745On the marketActive device

Manufacturer: J. MORITA MFG. CORP.
Manufacturer SRN: JP-MF-000023000
UDI-DI: 04548213042616
Basic UDI-DI: 4548213000B0004DT
Reference: HIM-2 Type EX2
EMDN: -
EMDN description: VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Dixel

Class IMDR 2017/745On the market

Manufacturer: J. MORITA MFG. CORP.
Manufacturer SRN: JP-MF-000023000
UDI-DI: 04548213030804
Basic UDI-DI: 4548213000B0022DV
Reference: i-Dixel
EMDN: -
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

X800

Class IIbMDR 2017/745On the marketActive device

Manufacturer: J. MORITA MFG. CORP.
Manufacturer SRN: JP-MF-000023000
UDI-DI: 04548213030798
Basic UDI-DI: 4548213000B0017E4
Reference: X800
EMDN: -
EMDN description: EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016900835
Basic UDI-DI: 88000169ST1XB
Reference: 1590-00001-301
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Extra Large Tip

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016902884
Basic UDI-DI: 88000169ST1XB
Reference: 1590-00013-001
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016902914
Basic UDI-DI: 88000169ST1XB
Reference: 1590-00014-001
EMDN: Z12040299
EMDN description: GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906157
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-30T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906164
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-50T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906171
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-50T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906188
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-100T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906195
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-100T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906201
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-200T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906218
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-200T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906225
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-300T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906232
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-300T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

CarePak 108 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906256
Basic UDI-DI: 8806712POCBGCT00429
Reference: POCBGCT004-100T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

CarePak 108 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906263
Basic UDI-DI: 8806712POCBGCT00429
Reference: POCBGCT004-200T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

CarePak 108 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906270
Basic UDI-DI: 8806712POCBGCT00429
Reference: POCBGCT004-200T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

CarePak 108 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906287
Basic UDI-DI: 8806712POCBGCT00429
Reference: POCBGCT004-300T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

CarePak 110 Cartridge

-

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906300
Basic UDI-DI: 8806712POCBGCT0052B
Reference: POCBGCT005-50T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details