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37 device results listed.

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Anti-k (Cellano) Mono-Type

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340483
Basic UDI-DI: 764013734Antis-C-118M9
Reference: 213209
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

Procleix Panther System (ART, Continuous Fluid and Waste)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00850032683753
Basic UDI-DI: 0850032683Panther001B4
Reference: PRD-06122
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 16:05

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Procleix Reagent Preparation Incubator 250

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00866489000067
Basic UDI-DI: 08664890000RPI00185
Reference: 740820
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 07:00

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Procleix Xpress System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00866489000005
Basic UDI-DI: 08664890000Xpress001YG
Reference: 718431
EMDN: W02060180
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 07:00

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Procleix Reagent Equilibration System

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007771
Basic UDI-DI: 0859882007RES001DS
Reference: 741597
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

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Procleix Parasite Transport Medium

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007757
Basic UDI-DI: 0859882007Procleix014ZK
Reference: 9051577
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

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Procleix Reagent Preparation Incubator

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007702
Basic UDI-DI: 0859882007RPI004FK
Reference: 740817
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

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Procleix Assay Fluids Kit

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007610
Basic UDI-DI: 0859882007Procleix011ZD
Reference: 303344
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

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Procleix SysCheck

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007405
Basic UDI-DI: 0859882007Procleix013ZH
Reference: 301046E
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

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Procleix Auto Detect Reagents

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00850032683579
Basic UDI-DI: 0859882007Procleix012ZF
Reference: 9053575
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:48

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Neutr-AB II

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341145
Basic UDI-DI: B-07640137341145
Reference: 213424
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 07.07.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Lua

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340957
Basic UDI-DI: B-07640137340957
Reference: 213553
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 07.07.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details

Grifols sCD38

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341589
Basic UDI-DI: 764013734sCD38HG
Reference: 213686
EMDN: W01030399
EMDN description: IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 03.07.2026 06:25

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Specific Albumin 30%

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341107
Basic UDI-DI: 764013734Albumin-002CW
Reference: 213573
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 03.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Albumin 22%

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341084
Basic UDI-DI: 764013734Albumin-001CU
Reference: 213422
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 03.07.2026 06:25

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Enlisst-II

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341077
Basic UDI-DI: 764013734Enlisst-IIMH
Reference: 213577
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 03.07.2026 06:25

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Procleix Auto Detect Reagents

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007627
Basic UDI-DI: 0859882007Procleix012ZF
Reference: 303345
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: -
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 21.06.2026 23:16

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