Manufacturer

Optomedic

ChinaLegal entities : Guangdong OptoMedic Technologies, Inc., Guangdong Optomedic Technologies, Inc.

Markets : Germany · Ireland · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 11 · class II · latest in 2026 · see on the FDA website

EU representative : Share info GmbH (Germany)

Website

11 categories, 33 models including 33 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
Surgical cameras	Z12020405	Endoscopic Fluorescence Camera Head OPTO-CHD2100,71-066-10 NIR2 refs Endoscopic Fluorescence Camera Head OPTO-CHD214KE, OPTO-CHD214KH,71-068-10 NIR,71-068-10 NIR-CA, 71-068-20 NIR,71-068-20 NIR-CA3 refs Stellar 3D Camera Head SC10D Stellar 3D Fluorescence Camera Head SC20D Stellar 3D Fluorescence Camera Head SC30D 3 others Stellar Camera Head SC10E Stellar Fluorescence Camera Head SC20E Stellar SC30E	I MDR	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	FloNavi Light source OPTO-LED2100,71-180-30 NIR2 refs FloNavi Light source OPTO-LED214K,71-182-30 NIR,71-182-30 NIR-CA2 refs Light source SL10 Light source SL20 Stellar Light Source SL30 1 other WhtNavi OPTO-LED104K	I, IIa MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	3D Reconstruction Workstation OPTO-FM2000 FloNavi Open Field Fluorescence Imaging Head OPTO-CHD3100E，71-066-55 NIR2 refs FloNavi Open Field Fluorescence Imaging Head OPTO-CHD314KE,71-068-55 NIR2 refs Fluorescence Image Analysis Workstation OPTO-FM1000, 71-920-00 NIR2 refs Open Field Fluorescence Imaging Head OPTO-CHD3100H, 71-066-50 NIR2 refs	I, IIa MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	OptoMedic 4K 3D Medical Monitor OPTO-3U32WP OptoMedic 4K UHD Medical Monitor OPTO-2U55WA OptoMedic Medical Monitor OPTO-2U32WA-P	I MDR	EUDAMED record Report an error
Video processors	Z12020406	FloNavi Image Processing Unit OPTO-CAM2100,71-066-05 NIR FloNavi Image Processing Unit OPTO-CAM214K,71-068-05 NIR,71-068-05 NIR-CA3 refs WhtNavi OPTO-CAM104K	I MDR	EUDAMED record Report an error
Laparoscopes	Z12029009	Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC3 refs Laparoscope 21033SA,21033SC2 refs	IIa MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - other	Z119099	Surgical Cart MTR-S100 Surgical Cart MTR-S200	I MDR	EUDAMED record Report an error
Gas inflators	Z12029008	Insufflator(with Insufflation Tube and Gas Filter) 4050039	IIb MDR	EUDAMED record Report an error
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - other	Z12020499	Stellar Image Processing Unit SI10E	I MDR	EUDAMED record Report an error
Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images	Z12020401	WhtNavi OPTO-CHD104KH	I MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - hardware accessories	Z12019080	Light Guide Cable FIB-H3045, FIB-H3545, FIB-H30353 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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