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148 device results listed.

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BioCLIA Autoimmune Control Set, C1q

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030417048
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02290
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403050

IM4410266 IM4411266 IM4414266 IM4415266

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403050
Basic UDI-DI: 69506174IM441266E3
Reference: IM4410266
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403043

IM4410266 IM4411266 IM4414266 IM4415266

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403043
Basic UDI-DI: 69506174IM441266E3
Reference: IM4411266
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403036

IM4410266 IM4411266 IM4414266 IM4415266

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403036
Basic UDI-DI: 69506174IM441266E3
Reference: IM4414266
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:39

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403029

IM4410266 IM4411266 IM4414266 IM4415266

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403029
Basic UDI-DI: 69506174IM441266E3
Reference: IM4415266
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:39

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402855

IM4403254 IM4402254 IM4407254 IM4409254

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402855
Basic UDI-DI: 69506174IM440254DM
Reference: IM4409255
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:39

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402848

IM4403254 IM4402254 IM4407254 IM4409254

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402848
Basic UDI-DI: 69506174IM440254DM
Reference: IM4407255
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:39

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402831

IM4403254 IM4402254 IM4407254 IM4409254

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402831
Basic UDI-DI: 69506174IM440254DM
Reference: IM4402255
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:39

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402824

IM4403254 IM4402254 IM4407254 IM4409254

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402824
Basic UDI-DI: 69506174IM440254DM
Reference: IM4403255
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:39

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ku

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416874
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02273
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ku

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416881
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02276C
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, Ku

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416898
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02281
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Ku

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416904
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02282
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Mi-2

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416843
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02275C
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, Mi-2

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416850
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02277
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Mi-2

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416867
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02278
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, C1q

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416911
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02285
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-nRNP/Sm IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359512985
Basic UDI-DI: 697015090000311H4
Reference: CMQ2110
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
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-nRNP/Sm IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359512961
Basic UDI-DI: 697015090000311H4
Reference: CMQ2108
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDot Myositis12 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680759
Basic UDI-DI: 542502368BDMYOSITIS74
Reference: MYO12D-24
EMDN: W0102100199
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details