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32 device results listed.

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Anti-Sm Antibody IgG CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424220010
Basic UDI-DI: B-06975424220010
Reference: 100 tests/kit
EMDN: W0102100111
EMDN description: SM
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Sm IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769444
Basic UDI-DI: B-06975070769444
Reference: 14000732
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Sm IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761059
Basic UDI-DI: B-06975070761059
Reference: 18116001
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sm-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004375
Basic UDI-DI: B-04049325004375
Reference: RE75221
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

EliA SmDP-S Well

EliA SmDP-S

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021485
Basic UDI-DI: 7333066BUDI0127M7
Reference: 14-5672-01
EMDN: W0102100111
EMDN description: SM
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

06950617406556

IM4402255 IM4403255 IM4409255 IM4407255

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617406556
Basic UDI-DI: 69506174IM440255DP
Reference: IM4407255
EMDN: W0102100111
EMDN description: SM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:44

Manufacturer products Authorised representative products Authorised representative actors View details

06950617406549

IM4402255 IM4403255 IM4409255 IM4407255

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617406549
Basic UDI-DI: 69506174IM440255DP
Reference: IM4409255
EMDN: W0102100111
EMDN description: SM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:44

Manufacturer products Authorised representative products Authorised representative actors View details

06950617406532

IM4402255 IM4403255 IM4409255 IM4407255

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617406532
Basic UDI-DI: 69506174IM440255DP
Reference: IM4403255
EMDN: W0102100111
EMDN description: SM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:44

Manufacturer products Authorised representative products Authorised representative actors View details

06950617406525

IM4402255 IM4403255 IM4409255 IM4407255

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617406525
Basic UDI-DI: 69506174IM440255DP
Reference: IM4402255
EMDN: W0102100111
EMDN description: SM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:44

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Sm IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359512893
Basic UDI-DI: 697015090000310H2
Reference: CMQ2010
EMDN: W0102100111
EMDN description: SM
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Sm IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359512879
Basic UDI-DI: 697015090000310H2
Reference: CMQ2008
EMDN: W0102100111
EMDN description: SM
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Sm Antibody IgG CLIA Assay Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222472
Basic UDI-DI: B-06975424222472
Reference: CL30372E
EMDN: W0102100111
EMDN description: SM
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details