Manufacturer

Wallac

FinlandLegal entities : Wallac Oy

Markets : Denmark · Finland · Italy

Approvals : EU – class A, C

Website regulatoryaffairs.turku@revvity.com

18 categories, 27 models including 25 on the market, 1 country

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
Nucleic acid testing instruments except micro-arrays - other	W02050199	chemagic 360-D chemagic Prepito-D chemagic Prime Jr-D	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Vanadis Core Vanadis Extract Vanadis View	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - IVD medical device software	W02079092	LifeCycle for Prenatal Screening3 refs98/79 LifeCycle Risk Calculation Engine BoBsoft2 refs98/79 (no longer marketed)	C IVDR, 98/79	EUDAMED record Report an error
Haematology reagents - other	W01030199	JB-2 Staining System RESOLVE Hb Elution Solution2 refs	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - other	W02079099	Panthera-Puncher 9 TriNEST	A IVDR	EUDAMED record Report an error
Chemistry instruments - other	W02010199	QSight 225 MD UHPLC Screening System QSight 210 MD Screening System (no longer marketed)	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	DELFIA Xpress	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	AutoDELFIA Automatic Immunoassay System2 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	GSP, Genetic Screening Processor	A IVDR	EUDAMED record Report an error
Capillary blood collection devices - other	W0501010299	Revvity 226 Sample Collection Device2 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - IVD medical device software	W0201010192	MSMS Workstation	A IVDR	EUDAMED record Report an error
Electrophoretic gel processors	W020105019001	Migele Gel Electrophoresis Unit (IVD)	A IVDR	EUDAMED record Report an error
Haemoglobin controls	W0103010504	RESOLVE Hb FASC Control Kit98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Victor2 D	A IVDR	EUDAMED record Report an error
Limited panel chemistry analysers - IVD medical device software	W0201010292	Eonis Analysis Software98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - hardware accessories	W02050180	Eonis Q96	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - software accessories	W02050182	Eonis EASI	A IVDR	EUDAMED record Report an error
Other haemoglobin (types) testing - other	W0103010299	RESOLVE Hemoglobin Kit3 refs98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.