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Allplex™ Bacterial Vaginosis plus Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101599
Basic UDI-DI: 924010SD10159GU
Reference: SD10159X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101186
Basic UDI-DI: 924010SD97500LQ
Reference: SD9750X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Candidiasis Assay

AllplexA™ Candidiasis Assay

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100738
Basic UDI-DI: 924010SD98030LF
Reference: SD9803X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Respiratory Pathogen Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930009
Basic UDI-DI: 89080153043B287NZ
Reference: 3B287/C
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 01.08.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

HIVFIND

HIVSST-01

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSterile

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459001672
Basic UDI-DI: 8905459HIVOSF9V
Reference: HIVSST-01
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/023 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

08905459000224

MBTREK-01 MBTREK-02

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000224
Basic UDI-DI: 8905459RNAEXTAU
Reference: MBTREK-01 MBTREK-02
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711268

302013

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711268
Basic UDI-DI: 888501971302013UA
Reference: 302013
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711251

302012

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711251
Basic UDI-DI: 888501971302012U8
Reference: 302012
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711152

800971

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711152
Basic UDI-DI: 888501971800971XQ
Reference: 800971
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711091

800945

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711091
Basic UDI-DI: 888501971800945XP
Reference: 800945
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711084

800941

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711084
Basic UDI-DI: 888501971800941XF
Reference: 800941
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711060

302014

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711060
Basic UDI-DI: 888501971302014UC
Reference: 302014
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711046

302011

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711046
Basic UDI-DI: 888501971302011U6
Reference: 302011
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711008

800842

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711008
Basic UDI-DI: 888501971800842XC
Reference: 800842
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710995

800841

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710995
Basic UDI-DI: 888501971800841XA
Reference: 800841
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710988

800816

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710988
Basic UDI-DI: 888501971800816XB
Reference: 800816
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710971

800815

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710971
Basic UDI-DI: 888501971800815X9
Reference: 800815
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710964

800814

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710964
Basic UDI-DI: 888501971800814X7
Reference: 800814
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710957

800813

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710957
Basic UDI-DI: 888501971800813X5
Reference: 800813
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710056

800827

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710056
Basic UDI-DI: 888501971800827XG
Reference: 800827
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details