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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

01.08.2026 18:27

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Device

2989865

Actor

47523

Certificate

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Active filter:EMDN:W01050108

220 device results listed.

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Mycoplasma pneumoniae IgG antibody Assay Reagent Kit (CMIA)

C2KJ014

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN
CN-MF-000004716
UDI-DI
06971792053496
Basic UDI-DI
B-06971792053496
Reference
C2KJ014
EMDN
W0105010802
EMDN description
MYCOPLASMA ANTIBODY ASSAYS
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 13:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
M.Pneumonia Antigen Rapid Test Device

K681416D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN
CN-MF-000004716
UDI-DI
06971792053182
Basic UDI-DI
B-06971792053182
Reference
K681416D
EMDN
W0105010801
EMDN description
MYCOPLASMA ANTIGEN DETECTION
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 13:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
M.Pneumonia IgG/IgM Rapid Test Device

K670216D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN
CN-MF-000004716
UDI-DI
06971792053151
Basic UDI-DI
B-06971792053151
Reference
K670216D
EMDN
W0105010802
EMDN description
MYCOPLASMA ANTIBODY ASSAYS
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 13:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
UU/TV/MG Multiplex Real Time PCR Kit

UU/TV/MG Multiplex Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229503
Basic UDI-DI
B-06971042229503
Reference
SD-0316-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Mycoplasma Hominis (MH)  Real Time PCR Kit

Mycoplasma Hominis (MH)  Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229480
Basic UDI-DI
B-06971042229480
Reference
SD-0279-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Mycoplasma Genitalium (MG) Real Time PCR Kit

Mycoplasma Genitalium (MG) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229473
Basic UDI-DI
B-06971042229473
Reference
SD-0278-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Ureaplasma parvum (UP) Real Time PCR Kit

Ureaplasma parvum (UP) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229466
Basic UDI-DI
B-06971042229466
Reference
SD-0267-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
UU/MH/MG/TV Multiplex Real Time PCR Kit

UU/MH/MG/TV Multiplex Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229459
Basic UDI-DI
B-06971042229459
Reference
SD-0252-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Ureaplasma Urealyticum (UU) Real Time PCR Kit

Ureaplasma Urealyticum (UU) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229404
Basic UDI-DI
B-06971042229404
Reference
SD-0015-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Mycoplasma Pneumoniae (MP) Real Time PCR Kit

Mycoplasma Pneumoniae (MP) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042227677
Basic UDI-DI
B-06971042227677
Reference
RD-0100-02
EMDN
W0105010803
EMDN description
MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 11:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
04251557109296

Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form F)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109296
Basic UDI-DI
B-04251557109296
Reference
86-03-56
EMDN
W010501080303
EMDN description
UREAPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:47
Manufacturer productsView details
04251557109289

Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form F)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109289
Basic UDI-DI
B-04251557109289
Reference
86-03-24
EMDN
W010501080303
EMDN description
UREAPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:47
Manufacturer productsView details
04251557109265

Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109265
Basic UDI-DI
B-04251557109265
Reference
86-02-56
EMDN
W010501080303
EMDN description
UREAPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:47
Manufacturer productsView details
04251557109234

Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form S)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109234
Basic UDI-DI
B-04251557109234
Reference
86-01-24
EMDN
W010501080303
EMDN description
UREAPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:47
Manufacturer productsView details
04251557109241

Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form S)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109241
Basic UDI-DI
B-04251557109241
Reference
86-01-56
EMDN
W010501080303
EMDN description
UREAPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:47
Manufacturer productsView details
04251557109258

Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109258
Basic UDI-DI
B-04251557109258
Reference
86-02-24
EMDN
W010501080303
EMDN description
UREAPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:46
Manufacturer productsView details
Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)

Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109227
Basic UDI-DI
B-04251557109227
Reference
85-03-56
EMDN
W010501080302
EMDN description
UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:46
Manufacturer productsView details
Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)

Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109210
Basic UDI-DI
B-04251557109210
Reference
85-03-24
EMDN
W010501080302
EMDN description
UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:46
Manufacturer productsView details
Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)

Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109197
Basic UDI-DI
B-04251557109197
Reference
85-02-56
EMDN
W010501080302
EMDN description
UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:46
Manufacturer productsView details
Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)

Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Astra Biotech GmbH
Manufacturer SRN
DE-MF-000026439
UDI-DI
04251557109180
Basic UDI-DI
B-04251557109180
Reference
85-02-24
EMDN
W010501080302
EMDN description
UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:46
Manufacturer productsView details