Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019648115

FEI Number

3019648115

Entity Name

SHANGHAI MAIKE BIOTECH CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

2 floor, buliding 9, 199 East Guangfulin Road, Shanghai, Shanghai 201613, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanghai Maike Biotech co., Ltd (Owner Number: 10082341)

Owner / Operator Contact Address

2 floor, buliding 9, 199 East Guangfulin Road, Shanghai, Shanghai, CN-SH 201613, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dolor Technology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2021-07-14

Official Correspondent

Michael Kuang

US Agent Details

Michael Kuang Email: 27633899@qq.com Phone: (314) 8997098

Related Public Records

Same Entity

Shanghai Maike Biotech co., Ltd

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

View Entity Profile →

Similar Registrations

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3031820558	BIGDAM INC	Atlanta, GA, US
3009141067	DOLOR TECHNOLOGIES LLC	Syracuse, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019648115. Last updated year: 2026. Please use registration number 3019648115 when referencing this establishment in official correspondence.