Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012544203

FEI Number

3012544203

Entity Name

DONGGUAN LANKE SILICONE TECHNOLOGY CO., LTD.

City/State/Country

DONGGUAN Guangdong, CN

Establishment Address

LUOMA LND. ZONE, LUOMA VILLAGE, QINGXI TOWN,, DONGGUAN Guangdong 523662, CN

Establishment Type(s)

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

Owner / Operator

DONGGUAN LANKE SILICONE TECHNOLOGY CO., LTD. (Owner Number: 10053237)

Owner / Operator Contact Address

LUOMA LND. ZONE, LUOMA VILLAGE, QINGXI TOWN,, DONGGUAN, CN-GD 523662, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2016-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

Ashleigh DePopas Email: ash@tryauggie.com Phone: (404) 6252069

Related Public Records

Same Entity

DONGGUAN LANKE SILICONE TECHNOLOGY CO., LTD.

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 3012544203. Last updated year: 2026. Please use registration number 3012544203 when referencing this establishment in official correspondence.