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Public EUDAMED Search

EUDAMED Device Search

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

TREN

Last updated

05.07.2026 22:24

Sync status

Successful

Device

2677257

Actor

47320

Certificate

3036

Active filter:Manufacturer SRN:AU-MF-000016649

36 device results listed.

Page 1 / 2

CSVXML
PlexPCR Flu/RSV/SARS-CoV-2

1.0

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224001365
Basic UDI-DI
9352224017031BNA
Reference
1703192
EMDN
W0105070302
EMDN description
OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
04.07.2026 00:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR RespiVirus (610)

1.0

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000108
Basic UDI-DI
9352224012010WA
Reference
1201001
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
04.07.2026 00:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR Colour Compensation

1.0

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000030
Basic UDI-DI
9352224090001YK
Reference
90001
EMDN
W0105080908
EMDN description
STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
04.07.2026 00:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PlexPCR VHS (550)

1.0

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
SpeeDx Pty. Ltd.
Manufacturer SRN
AU-MF-000016649
UDI-DI
09352224000078
Basic UDI-DI
9352224011210WD
Reference
1123001
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
Netherlands
Authorised representative
MedEnvoy Global BV
Last updated
04.07.2026 00:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details