Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017758228

FEI Number

3017758228

Entity Name

C-MER RAINSOPTICS LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Room 1328, Thriving Industrial Centre,, No. 26-38 Sha Tsui Road, Tsuen Wan, New Territories,, Hong Kong -, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

C-MER Rainsoptics Limited (Owner Number: 10074105)

Owner / Operator Contact Address

Room 1328, Thriving Industrial Centre,, No. 26-38 Sha Tsui Road, Tsuen Wan, New Territories,, Hong Kong, HK-NOTA -, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

C-MER RainsOptics, OphthoLens C-MER RainsOptics, Fundus Link pocket smartphone ophthalmoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2020-10-16

Official Correspondent

Rain Lee

US Agent Details

Eric Leung Business: LC & Partners LLC Email: eric@lcpartner.hk Phone: (801) 2011676

Related Public Records

Same Entity

C-MER Rainsoptics Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017758228. Last updated year: 2026. Please use registration number 3017758228 when referencing this establishment in official correspondence.