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157 device results listed.

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INMUNOGLOBULINA M

INMUNOGLOBULINA M (IgM)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155009849
Basic UDI-DI: B-08430155009849
Reference: 951535
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:31

Manufacturer products View details

INMUNOGLOBULINA M (IgM)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003745
Basic UDI-DI: B-18430155003745
Reference: 999008
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:00

Manufacturer products View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238734
Basic UDI-DI: B-06942202238734
Reference: 3014907
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin M

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819384
Basic UDI-DI: 6438153BU00110B9
Reference: 981938
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

Manufacturer products View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229527
Basic UDI-DI: B-06942202229527
Reference: 3004615
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

06955792740136

SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792740136
Basic UDI-DI: B-06955792740136
Reference: S2055E-150
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

06955792740129

SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792740129
Basic UDI-DI: B-06955792740129
Reference: S2055E-100
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

06955792740112

SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792740112
Basic UDI-DI: B-06955792740112
Reference: S2055E-75
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

06955792740105

SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792740105
Basic UDI-DI: B-06955792740105
Reference: S2055E-50
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260230
Basic UDI-DI: B-06942202260230
Reference: 3012519
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260223
Basic UDI-DI: B-06942202260223
Reference: 3021194
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202246852
Basic UDI-DI: B-06942202246852
Reference: 232020302006
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202216046
Basic UDI-DI: B-06942202216046
Reference: 3023577
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202216039
Basic UDI-DI: B-06942202216039
Reference: 3023557
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592903
Basic UDI-DI: B-06925794592903
Reference: 3021729
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:48

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592897
Basic UDI-DI: B-06925794592897
Reference: 3021696
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:48

Manufacturer products Authorised representative products Authorised representative actors View details

OS-IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514694310
Basic UDI-DI: B-05907514694310
Reference: 9-431
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:17

Manufacturer products View details

A-800 IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514678419
Basic UDI-DI: B-05907514678419
Reference: 7-841
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:16

Manufacturer products View details

A-400 IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514674053
Basic UDI-DI: B-05907514674053
Reference: 7-405
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:11

Manufacturer products View details

ACCENT-200 IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514672059
Basic UDI-DI: B-05907514672059
Reference: 7-205
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:10

Manufacturer products View details