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813 device results listed.

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D-IM4414265JV

Anti-PM-Scl Anitibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4414265JV
Basic UDI-DI: B-IM4414265JV
Reference: IM4414265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4414264JT

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4414264JT
Basic UDI-DI: B-IM4414264JT
Reference: IM4414264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4414257JW

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4414257JW
Basic UDI-DI: B-IM4414257JW
Reference: IM4414257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411265J8

Anti-PM-Scl Anitibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411265J8
Basic UDI-DI: B-IM4411265J8
Reference: IM4411265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411264J6

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411264J6
Basic UDI-DI: B-IM4411264J6
Reference: IM4411264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411257J9

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411257J9
Basic UDI-DI: B-IM4411257J9
Reference: IM4411257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4410265HZ

Anti-PM-Scl Anitibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4410265HZ
Basic UDI-DI: B-IM4410265HZ
Reference: IM4410265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4410264HX

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4410264HX
Basic UDI-DI: B-IM4410264HX
Reference: IM4410264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4410257J2

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4410257J2
Basic UDI-DI: B-IM4410257J2
Reference: IM4410257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409260KB

Anti-Jo-1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409260KB
Basic UDI-DI: B-IM4409260KB
Reference: IM4409260
EMDN: W0102100108
EMDN description: JO-1
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409258KQ

Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409258KQ
Basic UDI-DI: B-IM4409258KQ
Reference: IM4409258
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409256KL

Anti-SSA(Ro60) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409256KL
Basic UDI-DI: B-IM4409256KL
Reference: IM4409256
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409255KJ

Anti-Sm Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409255KJ
Basic UDI-DI: B-IM4409255KJ
Reference: IM4409255
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409254KG

Anti-Sm/RNP Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409254KG
Basic UDI-DI: B-IM4409254KG
Reference: IM4409254
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-dsDNA IgG

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76364G4
Basic UDI-DI: B-DC76364G4
Reference: DC76364
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-dsDNA IgG

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76363G2
Basic UDI-DI: B-DC76363G2
Reference: DC76363
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-dsDNA IgG

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76362FY
Basic UDI-DI: B-DC76362FY
Reference: DC76362
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-ANA

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76359GB
Basic UDI-DI: B-DC76359GB
Reference: DC76359
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-ANA

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76358G9
Basic UDI-DI: B-DC76358G9
Reference: DC76358
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-dsDNA IgG

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76361FW
Basic UDI-DI: B-DC76361FW
Reference: DC76361
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details