Manufacturer

Dornier

Germany, United StatesLegal entities : Dornier MedTech America, Inc., Dornier MedTech GmbH

Markets : France · Germany · Italy · Portugal · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 60 · PMA : 3 · class I, II, III · latest in 2025 · see on the FDA website

Public contracts won : Spain 18 · France 11 · Germany 2 · Italy 2 · Portugal 2

EU representative : Dornier MedTech Systems GmbH (Germany)

Website eudamed@dornier.com

9 categories, 18 models including 9 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
Shock wave therapy equipment	Z12139001	Dornier Aries93/42 Dornier Aries 23 refs93/42	IIb 93/42	EUDAMED record Report an error
Holmium surgical laser	Z12011003	Dornier Solvo H352 refs93/42 Dornier H100 Dornier Medilas H10093/42 (no longer marketed) Dornier H140 Dornier Medilas H14093/42 (no longer marketed) Dornier HRM2 refs93/42 (no longer marketed) Dornier Medilas H1002 refs93/42 (no longer marketed) 2 others Dornier Medilas H1402 refs93/42 (no longer marketed) Dornier Solvo H303 refs93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Electromechanical endoscopic lithotripters	Z12020301	Dornier Compact Sigma5 refs93/42 Dornier Delta III15 refs93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Central information computing systems	Z12030201	Dornier UIMS3 refs	IIb MDR	EUDAMED record Report an error
Diode-pumped solid-state (dpss) surgical laser	Z12011006	Dornier Thulio	IIb MDR	EUDAMED record Report an error
Extracorporeal lithotripters	Z12160101	Dornier Delta III3 refs	IIb MDR	EUDAMED record Report an error
Laser surgery instruments - consumables	Z12011085	Dornier 1000um SingleFlex Fiber3 refs	IIa MDR	EUDAMED record Report an error
Tilting tables for radiology equipment	Z11030504	Dornier Relax + Endo	I MDR	EUDAMED record Report an error
Diode surgical laser No model still on the market	Z12011016	Dornier Medilas D FlexiPulse2 refs93/42 (no longer marketed) Dornier Medilas D MultiBeam4 refs93/42 (no longer marketed)	IIb 93/42	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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