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EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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286 device results listed.

Page 14 / 15

IM4410040 IM4411040 IM4414040 IM4415040

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416487
Basic UDI-DI: 69506174IM441040D7
Reference: IM4414040
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410041 IM4411041 IM4414041 IM4415041

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416470
Basic UDI-DI: 69506174IM441041D9
Reference: IM4414041
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410041 IM4411041 IM4414041 IM4415041

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416449
Basic UDI-DI: 69506174IM441041D9
Reference: IM4411041
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410041 IM4411041 IM4414041 IM4415041

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416395
Basic UDI-DI: 69506174IM441041D9
Reference: IM4410041
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410041 IM4411041 IM4414041 IM4415041

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617411611
Basic UDI-DI: 69506174IM441041D9
Reference: IM4415041
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(550)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000023
Basic UDI-DI: 9352224020001W6
Reference: 2000201
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG Positive Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000047
Basic UDI-DI: 9352224020001W6
Reference: 95001
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(675)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000191
Basic UDI-DI: 9352224020001W6
Reference: 2000301
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000207
Basic UDI-DI: 9352224020001W6
Reference: 2000125
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(550)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000214
Basic UDI-DI: 9352224020001W6
Reference: 2000225
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG(675)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000221
Basic UDI-DI: 9352224020001W6
Reference: 2000325
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG FleXible

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000382
Basic UDI-DI: 9352224020001W6
Reference: S2A-2000410
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG S2A Positive Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000399
Basic UDI-DI: 9352224020001W6
Reference: S2A-95004
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG (LC480)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001433
Basic UDI-DI: 9352224020001W6
Reference: 99003
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG (7500)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001488
Basic UDI-DI: 9352224020001W6
Reference: 99002
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus MG (CFX)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001495
Basic UDI-DI: 9352224020001W6
Reference: 99008
EMDN: W010501080304
EMDN description: MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 26.06.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae IgM Rapid Test Kit

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581801
Basic UDI-DI: 697518250G118353G
Reference: G11835
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Mycoplasma Pneumoniae IgM test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803835
Basic UDI-DI: B-06936155803835
Reference: ITP15001-TC40
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:12

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Antigen Rapid Qualitative Test

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207985
Basic UDI-DI: B-06933260207985
Reference: BT0102601
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasmal Pneumonia IgM Rapid Qualitative Test

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207978
Basic UDI-DI: B-06933260207978
Reference: BT0102501
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details