UTSBridge

Public EUDAMED Search

EUDAMED Device Search

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

TREN

Last updated

22.09.2026 16:13

Sync status

Successful

Device

3538027

Actor

47762

Certificate

3388

Active filter:Manufacturer SRN:AU-MF-000016649

36 device results listed.

Page 2 / 2

CSVXML
PlexPCR RespiVirus Positive Control

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IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000139
Basic UDI-DI
9352224012010WA
Reference
95002
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
21.06.2026 17:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR RespiVirus (610)

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IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001051
Basic UDI-DI
9352224012010WA
Reference
1201192
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
21.06.2026 17:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS(610)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000146
Basic UDI-DI
9352224011210WD
Reference
1121001
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS(675)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000153
Basic UDI-DI
9352224011210WD
Reference
1125001
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS (7500)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001310
Basic UDI-DI
9352224011210WD
Reference
99004
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PLexPCR VHS (LC480)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001327
Basic UDI-DI
9352224011210WD
Reference
99005
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS (CFX)

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IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001334
Basic UDI-DI
9352224011210WD
Reference
99006
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR RespiVirus (LC480)

-

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001372
Basic UDI-DI
9352224012010WA
Reference
99011
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
-
Authorised representative
MedEnvoy Global BV
Last updated
17.06.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details