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11 device results listed.

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AutoScan PRO 4.0

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581002171
Basic UDI-DI: 8887581002171EV
Reference: EMC021
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 01.08.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

VIRCLIA® LOTUS

VCLTS-CL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040328286
Basic UDI-DI: 843604032VCLTS-CL012M
Reference: VCLTS-CL
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

AIX1000 Analyzer

00400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350004000
Basic UDI-DI: ++B35000400B5
Reference: 00400
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

AIX1000 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B35000400R0
Basic UDI-DI: ++B35000400RX4
Reference: 00400R
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplo Rapid TP/HIV Test

LAB S/P

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: MedMira Laboratories Inc.
Manufacturer SRN: CA-MF-000013928
UDI-DI: D-8153110050085Y
Basic UDI-DI: B-8153110050085Y
Reference: 815311005008
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplo Rapid TP/HIV Test

LAB+

IVD Annex II List AIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MedMira Laboratories Inc.
Manufacturer SRN: CA-MF-000013928
UDI-DI: D-8153110049957T
Basic UDI-DI: B-8153110049957T
Reference: 815311004995
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

Reveal Rapid HIV Test

815311000690 HIV LAB S/P

IVD Annex II List AIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MedMira Laboratories Inc.
Manufacturer SRN: CA-MF-000013928
UDI-DI: D-81531100069066
Basic UDI-DI: B-81531100069066
Reference: 815311000690
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

Reveal Rapid HIV Test

LAB +

IVD Annex II List AIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MedMira Laboratories Inc.
Manufacturer SRN: CA-MF-000013928
UDI-DI: D-8153110006075R
Basic UDI-DI: B-8153110006075R
Reference: 815311000607
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

SARA

S.A.R.A.

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616042033
Basic UDI-DI: 805061604INCS99
Reference: S.A.R.A.
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:38

Manufacturer products View details

AUTO-DAT

AUTODAT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328368
Basic UDI-DI: 803389132AUTODAT2005Y
Reference: 26001
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

Manufacturer products View details

ORPHIA Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616042767
Basic UDI-DI: 805061604INCS99
Reference: SARA_Gen2
EMDN: W0204
EMDN description: INFECTIOUS IMMUNOLOGY INSTRUMENTS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 07:47

Manufacturer products View details