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21 device results listed.

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iFlash-PM-Scl IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720331
Basic UDI-DI: 692591270259HU
Reference: C86081G
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

AESKULISA® PM-Scl

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500593
Basic UDI-DI: B-04250289500593
Reference: 3117
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

D-IM4415265K4

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-IM4415265K4
Basic UDI-DI: B-IM4415265K4
Reference: IM4415265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:34

Manufacturer products Authorised representative products Authorised representative actors View details

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-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-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

iFlash-PM-Scl IgG

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721277
Basic UDI-DI: 692591270259HU
Reference: C86081G-S
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PM-Scl Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226951
Basic UDI-DI: B-06975424226951
Reference: CL30322EN
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PM-Scl Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226487
Basic UDI-DI: B-06975424226487
Reference: CL20322EN
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PM-Scl Antibody 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: 06975424220041
Basic UDI-DI: B-06975424220041
Reference: 100 tests/kit
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Myositis Antibody Profile IgG (CLIA)

Model 4: PM-Scl 75

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070766306
Basic UDI-DI: B-06975070766306
Reference: 14000419
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Myositis Antibody Profile IgG (CLIA)

Model 3: PM-Scl 100

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070766290
Basic UDI-DI: B-06975070766290
Reference: 14000418
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Myositis Antibody Profile IgG (CLIA)

Model 10: Sharay Anti-PM-SCl 75 IgG,100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761639
Basic UDI-DI: B-06975070761639
Reference: 18176001
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Myositis Antibody Profile IgG (CLIA)

Model 9: Sharay Anti-PM-SCl 100 IgG,100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761622
Basic UDI-DI: B-06975070761622
Reference: 18175001
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-PM-Scl IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761301
Basic UDI-DI: B-06975070761301
Reference: 18107001
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
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

EliA PM-Scl Well

EliA PM-Scl

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015590
Basic UDI-DI: 7333066BUDI0108M3
Reference: 14-5602-01
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

06950617402732

IM4410265 IM4411265 IM4414265 IM4415265

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402732
Basic UDI-DI: 69506174IM441265DZ
Reference: IM4415265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402725

IM4410265 IM4411265 IM4414265 IM4415265

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402725
Basic UDI-DI: 69506174IM441265DZ
Reference: IM4414265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402718

IM4410265 IM4411265 IM4414265 IM4415265

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402718
Basic UDI-DI: 69506174IM441265DZ
Reference: IM4411265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402701

IM4410265 IM4411265 IM4414265 IM4415265

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402701
Basic UDI-DI: 69506174IM441265DZ
Reference: IM4410265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details