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GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.

China·CN-MF-000011588

Last updated September 17, 2026

Information

Country: China
Address: Suite 503, Building A, Golden Valley Intellicreation Community, Foshan Guangdong
Website: optomedic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 13418549683
PRRC Contact: —
EUDAMED SRN: CN-MF-000011588
FDA FEI Number: 3029968414
DUNS Number: —

Catalogue (59)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Insufflator(with Insufflation Tube and Gas Filter)	4050039	EUDAMED	Class IIb	Active
OptoMedic 4K UHD Medical Monitor	OPTO-2U55WA	EUDAMED	Class I	Active
Stellar 3D Camera Head	SC10D	EUDAMEDFDA UDI	Class I	Active
Insufflator(with Insufflation Tube and Gas Filter)	4050039	EUDAMED	Class IIb	Active
WhtNavi	4010021	EUDAMEDFDA UDI	Class I	Active
Stellar Imaging System	K241530	FDA 510(k)	Class II	Active
Insufflator (OPTO-IFL1000)	K252318	FDA 510(k)	Class II	Active
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH	K221781	FDA 510(k)	Class II	Active
FloNavi Endoscopic Fluorescence Imaging System	K221861	FDA 510(k)	Class II	Active
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)	K242513	FDA 510(k)	Class II	Active
FloNavi Open Field Fluorescence Imaging System	K230407	FDA 510(k)	Class II	Active
Insufflator (OPTO-IFL1000)	K231342	FDA 510(k)	Class II	Active
3D Laparoscope	K252697	FDA 510(k)	Class II	Active
Endoscopic Fluorescence Camera Head	71-068-10 NIR-CA	EUDAMEDFDA UDI	Class I	Active
Endoscopic Fluorescence Camera Head	71-068-20 NIR	EUDAMEDFDA UDI	Class I	Active
Surgical Cart	MTR-S100	EUDAMED	Class I	Active
Laparoscope	21033SC	EUDAMEDFDA UDI	Class IIa	Active
Stellar Fluorescence Camera Head	SC20E	EUDAMEDFDA UDI	Class I	Active
Stellar 3D Fluorescence Camera Head	SC30D	EUDAMED	Class I	Active
Laparoscope	21033SA	EUDAMEDFDA UDI	Class IIa	Active
FloNavi Open Field Fluorescence Imaging Head	OPTO-CHD3100H	EUDAMEDFDA UDI	Class IIa	Active
Light Guide Cable	FIB-H3045	EUDAMEDFDA UDI	Class I	Active
FloNavi Open Field Fluorescence Imaging Head	OPTO-CHD314KE	EUDAMEDFDA UDI	Class IIa	Active
Laparoscope	21033WC	EUDAMEDFDA UDI	Class IIa	Active
FloNavi Endoscopic Fluorescence Camera Head	OPTO-CHD214KH	EUDAMEDFDA UDI	Class I	Active
Endoscopic Fluorescence Camera Head	71-068-10 NIR	EUDAMEDFDA UDI	Class I	Active
FloNavi Light source	OPTO-LED2100	EUDAMEDFDA UDI	Class IIa	Active
Endoscopic Fluorescence Camera Head	71-068-20 NIR-CA	EUDAMEDFDA UDI	Class I	Active
WhtNavi	4020015	EUDAMEDFDA UDI	Class I	Active
OptoMedic 4K 3D Medical Monitor	OPTO-3U32WP	EUDAMED	Class I	Active
Image Processing Unit	71-068-05 NIR-CA	EUDAMEDFDA UDI	Class I	Active
Stellar	SC30E	EUDAMEDFDA UDI	Class I	Active
Light source	71-182-30 NIR	EUDAMED	Class IIa	Active
Stellar Camera Head	SC10E	EUDAMEDFDA UDI	Class I	Active
Laparoscope	21033FC	EUDAMEDFDA UDI	Class IIa	Active
Laparoscope	20533FA	EUDAMEDFDA UDI	Class IIa	Active
Light Guide Cable	FIB-H3035	EUDAMED	Class I	Active
Surgical Cart	MTR-S200	EUDAMED	Class I	Active
Light source	SL10	EUDAMEDFDA UDI	Class I	Active
FloNavi Image Processing Unit	OPTO-CAM2100	EUDAMEDFDA UDI	Class I	Active
Stellar 3D Fluorescence Camera Head	SC20D	EUDAMEDFDA UDI	Class I	Active
FloNavi Image Processing Unit	OPTO-CAM214K	EUDAMEDFDA UDI	Class I	Active
Stellar Light Source	SL30	EUDAMED	Class IIa	Active
Image Processing Unit	71-066-05 NIR	EUDAMED	Class I	Active
3D Reconstruction Workstation	OPTO-FM2000	EUDAMED	Class I	Active
FloNavi Endoscopic Fluorescence Camera Head	OPTO-CHD2100	EUDAMEDFDA UDI	Class I	Active
FloNavi Light source	OPTO-LED214K	EUDAMEDFDA UDI	Class IIa	Active
Open Field Fluorescence Imaging Head	71-066-55 NIR	EUDAMED	Class IIa	Active
WhtNavi	4030030	EUDAMEDFDA UDI	Class I	Active
FloNavi Open Field Fluorescence Imaging Head	OPTO-CHD3100E	EUDAMEDFDA UDI	Class IIa	Active

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FDA Establishments (1)

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Guangdong Optomedic Technologies, Inc. US