Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017994096

FEI Number

3017994096

Entity Name

Cleanmo (Dongguan) Biotech Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.6 Jinbu Road, Zhongtang Town, Dongguan Guangdong 523220, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Cleanmo Technology Co., Ltd. (Owner Number: 10064543)

Owner / Operator Contact Address

Room 908, 9/F., Building 13, Qinchengda, Zone 22, Xin'an Street, Bao'an District, Shenzhen, CN-GD 518101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iClean, CHGPrep,Swwip,Cleanmo Antiseptic Swab Sticks (CHG-SS-FS708L;CHG-SS-FS708;CHG-SS-FS707;CHG-SS-FS707S;CHG-CS2) Antiseptic Foam/Sponge Oropharyngeal Flocked Swab (CM-FS915;CM-FS916,CM-NS915) Specimen Collection Polyester Swab (CM-PS713;CM-PS761;CM-PS917) Specimen Collection Foam Swab (CM-FS712;CM-FS740;CM-FS-707;CM-FS708) DNA Flocked Swab(CM-FS913;CM-FS915;CM-FS916,CM-NS915,NFS913-LTP,NFS915-LTP, NFS916-LTP,CM-FS812) Antiseptic Swab Applicators Antiseptic Wipes (SA-105-2C7I,SA-260-2C7I,SASP-030-2C7I,SASP-050-2C7I,SASP-060-2C7I,SA-030-2C7I,SA-050-2C7I,SA-060-2C7I) Cervical Specimen Collection Flocked Swab(CM-FS919,CM- FS919D,CM-FS919K,CM-FS919V,CM-FS919T) Nasopharyngeal Flocked Swab (CM-FS913) CHG APPLICATORS (SA03-2C7I,SA03-2C7I-O,SA05-2C7I,SA05-2C7I-O,SA06-2C7I,SA06-2C7I-O,SA105-2C7I,SA105-2C7I-O) CHG APPLICATORS (SA150-2C7I,SA150-2C7I-O,SA210-2C7I,SA210-2C7I-O,SA260-2C7I,SA260-2C7I-O) Pipette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-03-26
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2021-01-03

Official Correspondent

Vivi Liu

US Agent Details

Yin Cheng Email: Usmethod@Foxmail.com Phone: (718) 4758261

Related Public Records

Same Entity

Shenzhen Cleanmo 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 3017994096. Last updated year: 2026. Please use registration number 3017994096 when referencing this establishment in official correspondence.