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147 device results listed.

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Allplex™ TS Strep ACG&AH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240105269
Basic UDI-DI: 924010RBIL00002PH
Reference: RBIL00002X
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MDRO Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102886
Basic UDI-DI: 924010MR10289KS
Reference: MR10288Z
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
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

Seegene STARlet

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240109007
Basic UDI-DI: 9240106793003XE
Reference: 67930-03
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Allplex™ HPV28 Detection

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103739
Basic UDI-DI: 924010HP10372FX
Reference: HP10373Z
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV28 Detection

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103722
Basic UDI-DI: 924010HP10372FX
Reference: HP10372X
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ NG & DR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103685
Basic UDI-DI: 924010SD10367H5
Reference: SD10368Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ NG & DR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103678
Basic UDI-DI: 924010SD10367H5
Reference: SD10367X
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MG & AziR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103197
Basic UDI-DI: 924010SD10170GG
Reference: SD10319Z
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details