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NOVEOS flex Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879028768
Basic UDI-DI: 081687902NOVINST37
Reference: FX64000
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Advena Limited
Last updated: 23.06.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Mix Container Pack

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879028775
Basic UDI-DI: 081687902NOVACCKX
Reference: FX64006
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Advena Limited
Last updated: 23.06.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Cuvette Pack

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879028782
Basic UDI-DI: 081687902NOVACCKX
Reference: FX64007
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Advena Limited
Last updated: 23.06.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-evaporation Caps

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879028805
Basic UDI-DI: 081687902NOVACCKX
Reference: FX64009
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Advena Limited
Last updated: 23.06.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Keylights Biotechnology (Chongqing) Co.,Ltd.
Manufacturer SRN: CN-MF-000033853
UDI-DI: 06975879670071
Basic UDI-DI: 697587967KLS00019Q
Reference: BioCLIA 1900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 23.06.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Keylights Biotechnology (Chongqing) Co.,Ltd.
Manufacturer SRN: CN-MF-000033853
UDI-DI: 06975879670101
Basic UDI-DI: 697587967KLS00019Q
Reference: BioCLIA 6900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 23.06.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S KRYPTOR compact SOLUTION 4

IVD Class ANot specifiedOn the market

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157633247
Basic UDI-DI: 426015763899BKCSol3-4XXFT
Reference: 89984
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 23.06.2026 18:04

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B·R·A·H·M·S Solution 3 KRYPTOR GOLD

IVD Class ANot specifiedOn the market

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638655
Basic UDI-DI: 426015763899BSol3-4KGXXLM
Reference: 89993
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 23.06.2026 18:04

Manufacturer products View details

AutoDELFIA Automatic Immunoassay System

IVD Class ANot specifiedOn the market

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147335022
Basic UDI-DI: 6438147AutoDELFIA_PPP2
Reference: 1235-5220
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:36

Manufacturer products View details

QuikRead go Plus Instrument

IVD Class ANot specifiedNot intended for EU marketDirect marking

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001713
Basic UDI-DI: 6438115QRgoPlusDR
Reference: 155377
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: -
Authorised representative: -
Last updated: 23.06.2026 11:08

Manufacturer products View details

QuikRead go Plus Instrument

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001706
Basic UDI-DI: 6438115QRgoPlusDR
Reference: 155375
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:08

Manufacturer products View details

QuikRead go Plus Instrument

IVD Class ANot specifiedNot intended for EU marketDirect marking

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001690
Basic UDI-DI: 6438115QRgoPlusDR
Reference: 155376
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: -
Authorised representative: -
Last updated: 23.06.2026 11:08

Manufacturer products View details

QuikRead go Instrument

IVD Class ANot specifiedNot intended for EU market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001263
Basic UDI-DI: 6438115QRgoInstrumentF8
Reference: 149915
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: -
Authorised representative: -
Last updated: 23.06.2026 11:07

Manufacturer products View details

QuikRead go Instrument

IVD Class ANot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115000181
Basic UDI-DI: 6438115QRgoInstrumentF8
Reference: 135867
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:06

Manufacturer products View details

QuikRead go Instrument

IVD Class ANot specifiedNot intended for EU marketDirect marking

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115000174
Basic UDI-DI: 6438115QRgoInstrumentF8
Reference: 136196
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: -
Authorised representative: -
Last updated: 23.06.2026 11:06

Manufacturer products View details

OC-SENSOR Ceres

IVD Class ANot specifiedOn the market

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026355214
Basic UDI-DI: 4987026TD-OCEQZ5
Reference: MV5K00
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

STROMATOLYSER-3WP

IVD Class ANot specifiedOn the market

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562022151
Basic UDI-DI: 4987562STROMATOLYSER3WPE8
Reference: 874-0331-9
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 22.06.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

Release 13AUG2012

IVD Class ANot specifiedOn the market

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280056
Basic UDI-DI: 574400328SOFTWE5
Reference: v12-0612
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 22.06.2026 05:14

Manufacturer products View details

Release 23SEP2013

IVD Class ANot specifiedOn the market

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280063
Basic UDI-DI: 574400328SOFTWE5
Reference: v13-0913
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 22.06.2026 05:14

Manufacturer products View details

Acidic clean for Histareader

IVD Class ANot specifiedOn the market

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280100
Basic UDI-DI: 574400328RINSECH
Reference: RLA709
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 22.06.2026 05:14

Manufacturer products View details