Manufacturer

Neitz

JapanLegal entities : Neitz Instruments Co., Ltd.

Markets : Germany · United States

Approvals : EU – class I · United States (FDA) – 510(k) : 24 · class I, II · latest in 1997 · see on the FDA website

EU representative : MDSS GmbH (Germany)

3 categories, 57 models including 57 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Ophthalmoscopes	Z12120114	Battery Pack 2000RC BS-III LED BXα-13 BXα-13-RX BXα-13A 30 others BXα-13A-RX BXα-RC BXα-RC-RX BXα13ALED BXα13ARXLED BXα13ARXSPLED BXα13LED BXα13RXLED BXα13RXSPLED BXαRCLED BXαRCRXLED BXαRCRXSPLED BXαRCUSBLED BXαRCUSBRXLED BXαRCUSBRXSPLED Desktop Charger RC4 Desktop Charger RC6 IO-Vega Basic Set IO-Vega Set-C IO-Vega Set-D IO-Vega Set-S IO-Vega Set-V IO-Vega Set-W IO-α LED (Battery-powered Type) Set 1 IO-α LED (Battery-powered Type) Set 2 IO-α LED (Battery-powered Type) Set 3 IO-α LED (Battery-powered Type) Set 4 IO-α LED CAMERA Teaching Mirror TM2 Wall-mounted Charger RC5	I MDR	EUDAMED record Report an error
Retinoscopes	Z12120118	Fixation Card Set FC RX head with 3V bulb RX head with 4V bulb RX head without bulb RX-3 13 others RX-3A RX-3ASP RX-3SP RX-RC RX-SP head without bulb RX3ALED RX3ASPLED RX3LED RX3SPLED RXRCLED RXRCSPLED RXRCUSBLED RXRCUSBSPLED	I MDR	EUDAMED record Report an error
Light sources	Z129004	NSI-X 100 mm Type 120V NSI-X 100 mm Type 230V NSI-X 80 mm Type 120V NSI-X 80 mm Type 230V	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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