Manufacturer

Grifols

Spain, Switzerland, United StatesLegal entities : Diagnostic Grifols, S.A., Grifols Diagnostic Solutions Inc., Medion Grifols Diagnostics AG

Markets : Czechia · France · Italy · Poland · Slovenia · Spain · United States

Approvals : EU – class A, B, C, D · United States (FDA) – 510(k) : 5 · class I, II · latest in 2019 · see on the FDA website

Public contracts won : Czechia 15 · Italy 11 · France 4 · Poland 1 · Slovenia 1

EU representative : Diagnostic Grifols, S.A. (Spain)

Website regulatoryaffairs_dxbu@grifols.com

19 categories, 51 models including 51 on the market, 3 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Other antigen typing reagents	W0103030501	Anti-Dia Dual Anti-H for DG Gel Anti-H Mono-Type Anti-k (Cellano) Mono-Type Anti-Kpa Dual 12 others Anti-Kpb Dual Anti-Lea for DG Gel Anti-Lea Mono-Type Anti-Leb for DG Gel Anti-Leb Mono-Type Anti-Lua98/79 Anti-Lua for DG Gel Anti-Lub Mono-Type Dual Anti-M Mono-Type Dual Anti-N (LN3/MN879) Mono-Type Anti-P1 Mono-Type Dual Anti-S Mono-Type2 refs	C IVDR, 98/79	EUDAMED record Report an error
Antibody identification cell panels	W0103030303	Data-Cyte Extend 0.8% Diego(a)-Cyte 0.8% Diego(a)-Cyte 3% Mi(a)-Cyte 0.8% Serascan Diana Dia	C IVDR	EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other	W0103020999	DG CellMedia DG Clean DG Fluid A2 refs DG Gel Sol	A IVDR	EUDAMED record Report an error
Automated blood grouping analysers	W0202030102	Erytra Erytra Eflexis WADiana Compact	A IVDR	EUDAMED record Report an error
Enhancement media (e.g. bovine albumin, liss, peg)	W0103030306	Enlisst-II Specific Albumin 22% Specific Albumin 30%	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - other	W02079099	Procleix Reagent Equilibration System Procleix Reagent Preparation Incubator Procleix Reagent Preparation Incubator 250	A IVDR	EUDAMED record Report an error
Centrifuges	W02069003	DG Spin DG Therm	A IVDR	EUDAMED record Report an error
Enzymes (e.g. bromelin / papain, etc.)	W0103030307	Bromelase 3098/79 DG-Papain98/79	– 98/79	EUDAMED record Report an error
Polyspecific antihuman serum	W0103030304	DG Gel DC Scan DG Gel DC Scan Plus	C IVDR	EUDAMED record Report an error
Abo typing tests - other	W0103030199	Anti-A1 Lectin Dual	C IVDR	EUDAMED record Report an error
Antibody detection (immunohaematology) - other	W0103030399	Neutr-AB II98/79	– 98/79	EUDAMED record Report an error
Blood grouping analysers - software accessories	W0202030182	Blood Typing Manager	A IVDR	EUDAMED record Report an error
Combined abo typing + rhesus d	W0103030901	DG Gel Confirm D	D IVDR	EUDAMED record Report an error
Immunohaematology (blood grouping) tests - other	W01030399	Grifols sCD38	B IVDR	EUDAMED record Report an error
Immunohematology readers	W0202030201	DG Reader Net	A IVDR	EUDAMED record Report an error
Monospecific antihuman serum	W0103030305	Anti-C3d	C IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Procleix Panther System2 refs	A IVDR	EUDAMED record Report an error
Rhesus phenotypes	W0103030202	Anti-Cw Mono-Type Dual	C IVDR	EUDAMED record Report an error
Robotic sample processing systems - hardware accessories	W02060180	Procleix Xpress System	A IVDR	EUDAMED record Report an error

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