Manufacturer

Randox

Northern IrelandLegal entities : Randox Laboratories Limited

Markets : Austria · Belgium · Finland · France · Ireland · Italy · Northern Ireland · Slovakia · United States

Approvals : EU – class A, B · United States (FDA) – 510(k) : 134 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Italy 5 · Slovakia 3 · France 1

Website

17 categories, 44 models including 44 on the market, 1 country

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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
Chemistry analysers - consumables	W0201010185	ACID WASH SOLUTION (AWS)2 refs ACID WASH SOLUTION (WASH SOLN. 3) ALKALINE DETERGENT (Alkaline Detergent) RX8108 ALKALINE WASH SOLUTION (WASH soln. 9) ANTI-BACTERIAL DETERGENT (Detergent) 8 others C1 SOLUTION (C1 SOLN)3 refs ETCHING (ETCH) I.S.E. CLEANER (ISE CLN) I.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH) I.S.E. DILUENT (ISE DIL)2 refs ISE BUFFER (ISE BUF) ISE DETERGENT (ISE DET) RX WASH CONCENTRATE (WASH conc. 1)3 refs	A IVDR	EUDAMED record Report an error
Capillary blood collection systems	W0501010201	Capillary Blood Sample Collection Kit A SCK10672 Capillary Blood Sample Collection Kit B SCK10673 Capillary Blood Sample Collection Kit C SCK10674 Capillary Blood Sample Collection Kit D SCK10719 Home Blood Sample Collection Kit EV4460 1 other Premium Capillary Blood Sample Collection Kit	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.)) SIGNAL REAGENT – EV701 (REAG SGNL – EV701)3 refs WASH BUFFER CONCENTRATE (BUF WASH (conc.))	A IVDR	EUDAMED record Report an error
Haematology controls - other	W0103010599	COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)98/79 COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)98/79 COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)98/79	– 98/79	EUDAMED record Report an error
Multiconstituent controls - inf.imm.	W0105080807	SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL POSITIVE)3 refs SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)2 refs SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)3 refs	B IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400)	W0201010105	RX daytona plus (with ISE)2 refs RX imola	A IVDR	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	SEROLOGY HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag CONTROL +) SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)	B IVDR	EUDAMED record Report an error
Faeces collection devices	W05019001	Microbiome Home Sample Collection Kit UNIVERSAL FAECAL SAMPLE COLLECTION KIT SCK10693	A IVDR	EUDAMED record Report an error
Venous or arterious blood collection devices - other	W0501010199	ConcizuTrace™ Sample Collection Kit3 refs VENOUS BLOOD SAMPLE COLLECTION KIT 13 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	evidence MULTISTAT	A IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	RX monaco	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (with ise mode test/h > 400 and <= 800)	W0201010106	RX modena	A IVDR	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	evidence INVESTIGATOR	A IVDR	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	REFERENCE SOLUTION (REF SOLN)	A IVDR	EUDAMED record Report an error
Micro-array analysers	W02050201	Randox Discovery	A IVDR	EUDAMED record Report an error
Multilevel blood controls	W0103010503	HAEMATOLOGY CONTROL - LEVEL 1,2,3 (HAEM CNTL - LEVEL 1,2,3)	B IVDR	EUDAMED record Report an error
Saliva collection devices	W05019002	Home Saliva Collection Kit SCK10654	A IVDR	EUDAMED record Report an error

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