Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016678387

FEI Number

3016678387

Entity Name

CHENGDE TECHNOLOGY CO., LTD

City/State/Country

Longgang Zhejiang, CN

Establishment Address

No.888-1088 Shiji Ave., Longgang Zhejiang 325802, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Chengde Technology Co., Ltd (Owner Number: 10063896)

Owner / Operator Contact Address

No.888-1088 Shiji Ave., Longgang City, CN-ZJ 325802, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CD9501 CD9503B CDM18 CD9501B CD9503 KN95 (PM2.5) Protective Mask CDP202B CD95010 CD9501C CD95010F CDP2011 CDP2016B CDK201B CDP201B CDF001 CDP201F CDP3011A CDP2011B CD95010W CDP2015B CDP3016 CD9501W CD9503 CD9503B CD9501 CD9501B CDM18 CD9501 CD9501B CDB201F in white CDB202B in white CDB201B in black CDB201F in black CDB202B in black CDB201B in white

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-06-03
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies	General Hospital	Class 2	880.6260	2020-06-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-22
QOZ	Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy	Unknown	Class N	N/A	2023-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

Angela Blackwell Business: Blackwell Device Consulting Email: angela@blackwelldevice.com Phone: (704) 4509934

Related Public Records

Same Entity

Chengde Technology Co., Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016678387. Last updated year: 2026. Please use registration number 3016678387 when referencing this establishment in official correspondence.