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Emdyca

Manufacturer

Alba Bioscience

United Kingdom (ex Northern Ireland)Legal entities : Alba Bioscience Limited

Markets : Austria · France · Italy · Northern Ireland · United States

Approvals : EU – class B · United States (FDA) – · class I, II

EU representative : Emergo Europe B.V. (Netherlands)

Website regulatory.registrations@alivedx.com

13 categories, 60 models including 60 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Other antigen typing reagents W0103030501
23 others
– 98/79 EUDAMED record Report an error
Immunohaematology controls - other W0103030499
4 others
– 98/79 EUDAMED record Report an error
Rhesus d W0103030201 – 98/79 EUDAMED record Report an error
Abo grouping cells W0103030101 – 98/79 EUDAMED record Report an error
Abo sera W0103030102 – 98/79 EUDAMED record Report an error
Antibody 3 cell screening W0103030308 – 98/79 EUDAMED record Report an error
Antibody identification cell panels W0103030303 – 98/79 EUDAMED record Report an error
Control kits (immunohaematology) W0103030402 – 98/79 EUDAMED record Report an error
Rhesus phenotypes W0103030202 – 98/79 EUDAMED record Report an error
Antibody detection (immunohaematology) - other W0103030399 B IVDR EUDAMED record Report an error
Coombs control cells W0103030401 – 98/79 EUDAMED record Report an error
Monospecific antihuman serum W0103030305 – 98/79 EUDAMED record Report an error
Polyspecific antihuman serum W0103030304 – 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.

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