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264 device results listed.

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QDx Instacheck™-II

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010204
Basic UDI-DI: 880613301020BG
Reference: FPRR039
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598241783
Basic UDI-DI: 6970277510045Z23
Reference: AFR-602
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983192309
Basic UDI-DI: 6970277510044WZP
Reference: AFR-701
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow (LF) Portable Reader Plus

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983170222
Basic UDI-DI: 6970277510019TZH
Reference: ATR-400
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

16-Channel Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983136471
Basic UDI-DI: 6970277510015PYV
Reference: AFR-800
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Dry-type Fluorescent Immunoassay Analyzer (Single channel)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983110082
Basic UDI-DI: 6970277510004YZ7
Reference: AFR-600
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983107471
Basic UDI-DI: 6970277510002PYF
Reference: AFR-200S
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow (LF) Reader Plus

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983105712
Basic UDI-DI: 6970277510002UYR
Reference: ATR-300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Elisa Plate Reader

DIA2000

IVD Class AIVDR 2017/746On the marketAnimal tissuesInstrumentMicrobial substancesProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302438
Basic UDI-DI: 6936895BS0182K
Reference: BS018
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Elisa Microplate Reader

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300212
Basic UDI-DI: 6936895BS0052A
Reference: BS005
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

06921026705264

Jet-iStar 800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Joinstar Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001083
UDI-DI: 06921026705264
Basic UDI-DI: 69210267JS800GJ
Reference: JS800
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

TestiQ

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Novum Sp. z o.o.
Manufacturer SRN: PL-MF-000048483
UDI-DI: 05905351316679
Basic UDI-DI: 5905351316BNA100UY
Reference: BNA-100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:02

Manufacturer products View details

Lysis reagent (HClO4 - 7%), 10 mL

Lysis reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280285
Basic UDI-DI: 5744003280LYSIS5N
Reference: RLA704
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

IL-3, 0,1 µg

IL-3

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280292
Basic UDI-DI: 5744003280IL34Q
Reference: RLR004
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Stop reagent (HClO4), 100 mL

Stop reagent (HClO4)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280247
Basic UDI-DI: 574400328STOPFW
Reference: RLR011
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Stripping buffer, 100 mL

Stripping buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280261
Basic UDI-DI: 5744003280STRIP6M
Reference: RLA701
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Diluent (NaOH), 10 mL

Diluent (NaOH)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280223
Basic UDI-DI: 574400328DILUENTGG
Reference: RLR009
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

OPA Disc 25 mg, 20 pcs

OPA Discs

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280193
Basic UDI-DI: 574400328OPAHN
Reference: RLA708
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Wash buffer 200 mL

Wash buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280155
Basic UDI-DI: 574400328WASHDP
Reference: RLR007W.200
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Pipes buffer 100 mL

Pipes buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280124
Basic UDI-DI: 574400328PIPESBP
Reference: RLR006
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details