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EasyScreen™ Sample Processing Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genetic Signatures Ltd
Manufacturer SRN: AU-MF-000030901
UDI-DI: 09351179000003
Basic UDI-DI: 93511790SP012L7
Reference: SP012
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Greece
Authorised representative: mdi Europa GmbH
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Prep Tissue Digestion Kit

Buffers (Unassignable ), Supplem. Reagents, etc

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006197
Basic UDI-DI: 93430440W01059002015C
Reference: 90241
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

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MT-Prep Viral/Pathogen Nucleic Acids Extraction kit B (48 samples)

Nucleic acid Extraction/isolation Kit IVD

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003585
Basic UDI-DI: 93430440W010590010157
Reference: 93010
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

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Demi DNA Reagent Cassette

Nucleic acid amplification mastermix reagent IVD

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003073
Basic UDI-DI: 93430440W010590010259
Reference: 40241
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

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Extraction Control

Supplemental NA Reagents

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002571
Basic UDI-DI: 93430440W01059001035B
Reference: 91401
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

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STARprep™ EZ Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000373
Basic UDI-DI: 924000EX00038G3
Reference: EX00038B
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

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STARMag™ S96H N Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000359
Basic UDI-DI: 924000EX00036FX
Reference: EX00036P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

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STARMag™ S96H Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000311
Basic UDI-DI: 924000EX00032FP
Reference: EX00032P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag™ N/S Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000304
Basic UDI-DI: 924000EX00031FM
Reference: EX00031C
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag™ M96 Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000281
Basic UDI-DI: 924000EX00029G2
Reference: EX00029P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag™ SP32 Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000267
Basic UDI-DI: 924000EX00028FY
Reference: EX00028P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag 96 ProPrep C

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000175
Basic UDI-DI: 924000EX00017FT
Reference: EX00017P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag 96 x 4 Viral DNA/RNA 200 C Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000137
Basic UDI-DI: 924000EX00013FK
Reference: EX00013C
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag 96 ProPrep plus

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000113
Basic UDI-DI: 924000EX00010FD
Reference: EX00010P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag 96 ProPrep

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000090
Basic UDI-DI: 924000EX00009FU
Reference: EX00009P
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag 96 x 4 UniVersal plus Cartridge Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000069
Basic UDI-DI: 924000EX00006FN
Reference: EX00006C
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

STARMag 96 x 4 UniVersal Cartridge Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240000007
Basic UDI-DI: 9240007443004UC
Reference: 744300.4.UC384
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Bacterial DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930771
Basic UDI-DI: 8906213933B371YW
Reference: 3B372
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Bacterial/Fungal DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930801
Basic UDI-DI: 8906213933B345YV
Reference: 3B346
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Blood DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931020
Basic UDI-DI: 8906213933B205YC
Reference: 3B206
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details