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LYSUN

FCRAH-S26（1PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712025949Q
Basic UDI-DI: B-69717712025949Q
Reference: FCRAH-S26（1PCS）
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 04:00

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

COV-201（1PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712023899M
Basic UDI-DI: B-69717712023899M
Reference: COV-201（1PCS）
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 04:00

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

FCR-S23（1PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-6971771201979A9
Basic UDI-DI: B-6971771201979A9
Reference: FCR-S23（1PCS）
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:59

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B/COVID-19/ RSV Antigen Rapid Test

Influenza A+B/ COVID-19/ RSV Antigen Rapid Test

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 6971771200859
Basic UDI-DI: B-6971771200859
Reference: Influenza A+B/ COVID-19/ RSV Antigen Rapid Test
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Lithuania
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:50

Manufacturer products Authorised representative products Authorised representative actors View details

EZ POC System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133090633
Basic UDI-DI: 880613309063DS
Reference: FPCC154
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

ez-Tracker System check cartridge

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133081389
Basic UDI-DI: 880613308138DR
Reference: ET001-SC
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

QDx Instacheck™ System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133081488
Basic UDI-DI: 880613308148DU
Reference: FPCC156
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133030172
Basic UDI-DI: 880613303017C9
Reference: FPCC152
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Trio

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010617
Basic UDI-DI: 880613301061BW
Reference: FPRR056
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Alchemis

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010488
Basic UDI-DI: 880613301048C6
Reference: FPRR048
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ez-Track¹

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010426
Basic UDI-DI: 880613301042BS
Reference: FPRR019-15
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-3

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010341
Basic UDI-DI: 880613301034BT
Reference: FPRR040
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-10

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010310
Basic UDI-DI: 880613301031BM
Reference: FPRR038
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™-50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010266
Basic UDI-DI: 880613301026BU
Reference: FPRR022
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™-50 PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010334
Basic UDI-DI: 880613301033BR
Reference: FPRR036
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

EZ POC Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010259
Basic UDI-DI: 880613301025BS
Reference: FPRR034
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010129
Basic UDI-DI: 880613301012BH
Reference: FPRR035
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010112
Basic UDI-DI: 880613301011BF
Reference: FPRR031
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-1

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010051
Basic UDI-DI: 880613301005BL
Reference: FPRR019
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-6

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010037
Basic UDI-DI: 880613301003BG
Reference: FPRR020
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details