Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009349165

FEI Number

3009349165

Entity Name

MIRA MEDSOURCE (SHANGHAI) CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

UnitA, 23F, HuaXinHaiXin Building, 666 FuZhou Road, Huangpu District, Shanghai 200001, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Mira MEDsource (Shanghai) Co., Ltd. (Owner Number: 10039008)

Owner / Operator Contact Address

UnitA,23F, HuaXinHaiXin Building, 666 FuZhou Road, Huangpu District, Shanghai, CN-SH 200001, 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
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-04-17
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2012-02-16
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-05-24
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-11-05

Official Correspondent

Angela Bunn

US Agent Details

Angela Bunn Business: O&M Halyard, Inc. Email: Angela.Bunn@owens-minor.com Phone: (770) 4011697

Related Public Records

Same Entity

Mira MEDsource (Shanghai) 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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Similar Registrations

Registration Number	Establishment Name	Location
3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009349165. Last updated year: 2026. Please use registration number 3009349165 when referencing this establishment in official correspondence.