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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

05744003280117

Reagent kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280117
Basic UDI-DI: 574400328REAGK8U
Reference: RLA700
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

Detergent for Histareader

Rinse solutions for Histareader

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280094
Basic UDI-DI: 574400328RINSECH
Reference: RLA705
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

Release 23SEP2013

ver 3.0-0612

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280049
Basic UDI-DI: 574400328SOFTWE5
Reference: v4.0-0613
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Histareader501-1

501

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280025
Basic UDI-DI: 574400328READER8M
Reference: RLA501-1
EMDN: W0201020280
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Release 13AUG2012

ver 3.0-0612

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280032
Basic UDI-DI: 574400328SOFTWE5
Reference: v3.0-0612
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:32

Manufacturer products View details

Histareader501

501

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280018
Basic UDI-DI: 574400328READER8M
Reference: RLA501
EMDN: W0201020280
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:32

Manufacturer products View details

Portable Lateral Flow (LF) Reader

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830252
Basic UDI-DI: 5060599400002TP3
Reference: RT-ATR-001
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830245
Basic UDI-DI: 5060599400002PNT
Reference: RL-FA-2A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow Reader Plus

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830061
Basic UDI-DI: 5060599400002UP5
Reference: RL-RD-3A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer MPQuanti™

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

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315632
Basic UDI-DI: 42601633107IMA001J6
Reference: 07IMA001
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:39

Manufacturer products View details