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intelliPATH FLX™ Peroxidase Blocking Reagent

Peroxidase Blocking Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627008800
Basic UDI-DI: 08476270BPERBLKRZ9
Reference: IPB5000G20
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

MACH 4 MR Universal AP Detection System

MACH Mirco-Polymer Detection System for IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005175
Basic UDI-DI: 08476270BMACH421JC
Reference: BRI4005L
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

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Protein Blocking Reagents for IHC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005120
Basic UDI-DI: 08476270BBP974B7
Reference: BP974H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

Betazoid DAB Chromogen Kit

Betazoid DAB Chromogen Kits for IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005076
Basic UDI-DI: 08476270BBDB200486
Reference: BDB2004H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

4plus Universal AP Detection

LSAB (Streptavidin) Detection Systems for IHC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003812
Basic UDI-DI: 08476270BLSABKE
Reference: AP506US
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

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CP-CRP

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778147
Basic UDI-DI: 697806677SE007P2
Reference: 7070-PA00004
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778154
Basic UDI-DI: 697806677SE007P2
Reference: 7070-PA00005
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778161
Basic UDI-DI: 697806677SE007P2
Reference: 7070-PA00006
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 HCG Sample Diluent

IVDR_67_LLB_DUB-C_A_REAG_HCG Sample Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414965758
Basic UDI-DI: 0405686901333V8
Reference: 10387622
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Vitamin B12 Sample Diluent

IVDR_67_LLB_DUB-C_A_REAG_Vitamin B12 Sample Diluent

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414954448
Basic UDI-DI: 0405686900222UP
Reference: 10386999
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Total Triiodothyronine Diluent (T3 DIL)

IVDR_67_TTN_DUB-C_A_REAG_T3 Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599939
Basic UDI-DI: 0405686901583VZ
Reference: 10995680
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur CsA Pretreatment Reagent

IVDR_67_TTN_DUB-C_C_REAG_CsA Pretreatment Reagent

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414524474
Basic UDI-DI: 0405686901842W2
Reference: 10335453
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Betazoid DAB Chromogen Kit

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005083
Basic UDI-DI: 08476270BBDB200486
Reference: BDB2004L
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Betazoid DAB Chromogen Kit

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005090
Basic UDI-DI: 08476270BBDB200486
Reference: BDB2004MM
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Background Punisher

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005137
Basic UDI-DI: 08476270BBP974B7
Reference: BP974L
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Background Punisher

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005144
Basic UDI-DI: 08476270BBP974B7
Reference: BP974M
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

MACH 4 Universal HRP-Polymer Detection System

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005199
Basic UDI-DI: 08476270BMACH421JC
Reference: BRl4012G
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

MACH 4 Universal HRP-Polymer Detection System

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005205
Basic UDI-DI: 08476270BMACH421JC
Reference: BRI4012H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

MACH 4 Universal HRP-Polymer Detection System

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005212
Basic UDI-DI: 08476270BMACH421JC
Reference: BRI4012L
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Background Sniper

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005267
Basic UDI-DI: 08476270BBP974B7
Reference: BS966H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details