Manufacturer

Haag-Streit

SwitzerlandLegal entities : Haag-Streit AG

Markets : Bulgaria · France · Germany · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 6 · class I, II · latest in 2014 · see on the FDA website

Public contracts won : Germany 2 · France 1

EU representative : Haag-Streit Deutschland GmbH (Germany)

Website regulatory@haag-streit.com

10 categories, 39 models including 35 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
Instruments for operative microscopy - hardware accessories - other	Z1201118099	Beam Splitter T NEO 900 Beam Splitter2 refs Cap 12D x 193 refs EIBOS 22 refs Foot Switch EF 5000 NEO 900 Foot Switch2 refs Metis 3D Digital Heads Up Modules 6 others NEO 900 1/3" Camera Attachement2 refs NEO 900 C.MOR HD2 refs NEO 900 HS MIOS 5 NEO 900 TOCULAR Stereoscopic co-observer 0° NEO 900 Stereoscopic co-observer2 refs VERTISCOPE T NEO 900 VERTISCOPE2 refs	I MDR	EUDAMED record Report an error
Slit lamps	Z12120108	Camera Module CM023 refs Contrast Enhancing Filter2 refs Elara 900 Elara 900 VS Headrest HR-A3 refs 1 other Slit Lamp BI 9003 refs	I, IIa MDR	EUDAMED record Report an error
Tonometers	Z12120122	Applanation Tonometer3 refs Applanation Tonometer AT 87093/42 Applanation Tonometer AT 900 model BQ AT 900 BQ4 refs93/42 Applanation Tonometer AT 900 model R AT 900 R93/42 Applanation Tonometer AT 900 model T AT 900 T93/42 4 others AT 900 D BQ3 refs93/42 (no longer marketed) AT 900 D R93/42 (no longer marketed) AT 900 D T93/42 (no longer marketed) Measuring Prism93/42 (no longer marketed)	I MDR, 93/42	EUDAMED record Report an error
Computerised optical biometers	Z12120102	Biometer Lenstar LS 900 APS2 refs Eyestar 90093/42 EyeSuite IOL2 refs EyeSuite Myopia T-Cone	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Operative microscopes	Z12011101	Assistant scope w. mag. changer 5-step Metis 9002 refs HS Hi-R NEO 900 Microscope2 refs	I MDR	EUDAMED record Report an error
Visual functional assessment equipment	Z1212012001	Octopus 60093/42 Octopus 90093/42	IIa 93/42	EUDAMED record Report an error
Instruments for operative microscopy - software accessories	Z12011182	IOL Guide	IIa MDR	EUDAMED record Report an error
Instruments for the assessment of visual functionality - other	Z1212012099	Phoropter Refractor 9002 refs	I MDR	EUDAMED record Report an error
Peripheral vision analysers	Z1212012003	Octopus 910	IIa MDR	EUDAMED record Report an error
Stands for operative microscopy	Z1201118001	FS 2-25 HS NEO 900 Carrier	I MDR	EUDAMED record Report an error

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