Manufacturer

Arthrex

United StatesLegal entities : Arthrex Inc.

Markets : Belgium · Czechia · France · Germany · Italy · Netherlands · Poland · Slovakia · Spain · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 357 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 152 · Spain 73 · Czechia 41 · Italy 32 · Belgium 8 · Germany 8 · Poland 4 · Slovakia 1

EU representative : Arthrex GmbH (Germany)

Website

13 categories, 25 models including 25 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
Platelets concentrate transfer bags and kits	B010202	ARTHREX ACP TM DOUBLE SYRINGE93/42 ARTHREX ANGEL BMC KIT93/42 ARTHREX ANGEL PRP KIT (EU VERSION)93/42 Arthrex® ACP DOUBLE SYRINGE FOR ESTHETIC MEDICINE93/42 Arthrex® ACP DOUBLE SYRINGE W/ CROMA DESIGN93/42 5 others Arthrex® ACP KIT SERIES I93/42 Arthrex® ACP Max PRP System93/42 Arthrex® ACP Max PRP System (PCT)93/42 Arthrex® ACP Max PRP System (w/o ACDA)93/42 Arthrex® ANGEL cPRP PROCESSING SET EU93/42	IIa 93/42	EUDAMED record Report an error
Platelet gel automatic preparation devices (excluding bags)	B0501	Arthrex® ACP Max Counterbalance93/42 Arthrex® ANGEL CENTRIFUGE EU (REFURBISHED)93/42 Arthrex® ANGEL PRP SYSTEM CENTRIFUGE EU (NEW)93/42 Arthrex® COUNTWT C-FUGE ACP DBL SYRNGE 15ML93/42	IIa 93/42	EUDAMED record Report an error
Arthroscopes	Z12021101	Arthrex®3 refs	IIa MDR	EUDAMED record Report an error
Collection and filtration of whole blood with aliquotation of concentrated red blood cells bags and kits	B019002	Arthrex® Thrombinator™ System93/42	IIa 93/42	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	Arthrex®7 refs	I, IIa MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - other	Z12130599	Arthrex®3 refs	IIa MDR	EUDAMED record Report an error
Orthopaedic endoscopy instruments - other	Z12021199	Arthrex®9 refs	IIa MDR	EUDAMED record Report an error
Orthopaedic surgical drills	Z12130503	Arthrex®6 refs	I MDR	EUDAMED record Report an error
Patient positioning instruments - other	Z12011299	Arthrex®3 refs	I MDR	EUDAMED record Report an error
Spinoscopes	Z12020903	Arthrex®3 refs	IIa MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	Arthrex®	I MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	Arthrex89 refs	I, IIa MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - other	Z12139099	Arthrex®3 refs	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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