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Q-STATION ELITE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480276
Basic UDI-DI: 880944648QST09SA
Reference: MQST0901
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

08809408862782

S-Blot 2 Easy PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862782
Basic UDI-DI: 88094088SEP-001TD
Reference: SEPD001E
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

08809408862041

S-Blot 2 Easy

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862041
Basic UDI-DI: 88094088SEY-001WG
Reference: SEYD001E
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

08809408861631

S-Blot 2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408861631
Basic UDI-DI: 88094088SBT-001TJ
Reference: SBTD001E
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

08809408861624

S-Blot 3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408861624
Basic UDI-DI: 88094088SBF-001NQ
Reference: SBFD001E
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

FREND System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540207
Basic UDI-DI: 880931754FRENDKQ
Reference: F10
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-1H

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010600
Basic UDI-DI: 880613301060BU
Reference: FPRR054
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ II

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010044
Basic UDI-DI: 880613301004BJ
Reference: FPRR021
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

08806120502125

MESSIAH Gamma Counter

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shinjin Medics Inc.
Manufacturer SRN: KR-MF-000035809
UDI-DI: 08806120502125
Basic UDI-DI: 880612050212BK
Reference: DG02
EMDN: W0201020203
EMDN description: GAMMA COUNTERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

08806120502132

MESSIAH R4200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shinjin Medics Inc.
Manufacturer SRN: KR-MF-000035809
UDI-DI: 08806120502132
Basic UDI-DI: 880612050213BM
Reference: MR01
EMDN: W0201020203
EMDN description: GAMMA COUNTERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i pre-Trigger

i-PTR-01

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722691
Basic UDI-DI: 88001117IPAA05IA01WJ
Reference: 16PTR10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Trigger

i-TRG-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722684
Basic UDI-DI: 88001117IPAA06IA01WV
Reference: 16TR10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Wash buffer

i-WBF-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722677
Basic UDI-DI: 88001117IPAA07IA01X8
Reference: 16WB10
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Cleanser

i-CLE-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722660
Basic UDI-DI: 88001117IPAA04IA01W7
Reference: 16CL10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i2000

i2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111720260
Basic UDI-DI: 88001117IPAA01IA02V8
Reference: 16IA200
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i1000

i1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111720253
Basic UDI-DI: 88001117IPAA01IA01V6
Reference: 16IA100
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ABOSOL

ABSOL-001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Absology Co., Ltd.
Manufacturer SRN: KR-MF-000026041
UDI-DI: 08800069000001
Basic UDI-DI: 88000690ABSOLHY
Reference: ABSOL-001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

ASFA Scanner

MBD-SC4C-S

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: MBD Co., Ltd.
Manufacturer SRN: KR-MF-000026682
UDI-DI: 08800066300005
Basic UDI-DI: 8800066300005WS
Reference: MBD-SC4C-S
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Javitech Consulting GmbH
Last updated: 03.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

08800047500110

ATPI03

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PCL Inc.
Manufacturer SRN: KR-MF-000029608
UDI-DI: 08800047500110
Basic UDI-DI: 88000475ATPI03GL
Reference: PCLOK II
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900104

SimplexTAS 101 Heating Block

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

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900104
Basic UDI-DI: 880003790010AY
Reference: T0001002
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details