Manufacturer

Terumo BCT

Northern Ireland, United StatesLegal entities : Terumo BCT, Inc., Terumo BCT, Ltd.

Markets : Austria · Belgium · Croatia · Czechia · Finland · France · Germany · Hungary · Ireland · Italy · Netherlands · Norway · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 9 · class I, II, III · latest in 2019 · see on the FDA website

Public contracts won : France 25 · Czechia 12 · Hungary 10 · Sweden 6 · Croatia 5 · Spain 5 · Belgium 2 · Germany 2 · Italy 2 · Austria 1 · Finland 1 · Ireland 1 and 2 more countries

EU representative : Terumo BCT Europe N.V. (Belgium)

Website eudamed@terumobct.com

9 categories, 17 models including 17 on the market, 2 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
Apheresis collection devices - other	B030199	Accessory Waste Bag2 refs Spectra Optia™ Anticoagulant Adapter Anticoagulant Connection Adaptor2 refs Spectra Optia™ Exchange Set Spectra Optia Exchange Sets3 refs Spectra Optia™ Single Needle Connector Spectra Optia Single Needle Adaptor Spectra Optia™ SPD-C Connection Set Spectra Optia SPD-C Connection Set2 refs 2 others T-RAC II -Wifi Terumo Recording and Automatic Blood Collector (T-RAC II) T-RAC II Desktop Remote Control T-RAC II (Accessories)3 refs	I, IIa MDR	EUDAMED record Report an error
Donor blood collection quintuple bags, with filters and kits	B0101020102	Reveos LR EXT93/42 Reveos NLR2 refs93/42	IIb 93/42	EUDAMED record Report an error
Phototherapy equipment	Z12040202	Mirasol™ Illuminator Mirasol Illuminator Mirasol™ Radiometer Mirasol Radiometer	I, IIa MDR	EUDAMED record Report an error
Apheresis devices - accessories	B0380	Trima® Seal Safe System	I MDR	EUDAMED record Report an error
Bioimaging processors	Z11069001	Mirasol™ Manager Mirasol Manager	IIa MDR	EUDAMED record Report an error
Blood transfusion instruments - other	Z121799	Reveos™ Automated Blood Processing System Reveos Automated Whole Blood Processing System2 refs	IIa MDR	EUDAMED record Report an error
Donor blood collection quadruple bags, with filters and kits	B0101020101	Reveos LR2 refs93/42	IIb 93/42	EUDAMED record Report an error
Platelets concentrate transfer bags and kits	B010202	Reveos™ Platelet Pooling Set Reveos Platelet Pooling Set2 refs	IIa MDR	EUDAMED record Report an error
Pneumatic tourniquets	Z12139006	T-Cuff®	I MDR	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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