Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007084590

FEI Number

3007084590

Entity Name

SHAANXI ANSEN MEDICAL TECHNOLOGY DEVELOPMENT CO.,LTD.

City/State/Country

Xi'an Shaanxi, CN

Establishment Address

No 29 Junxian Road, Northwest Furniture Industrial Park, Lantian, Xi'an Shaanxi 710523, CN

Establishment Type(s)

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

Owner / Operator

Shaanxi Ansen Medical Technology Development Co., Ltd (Owner Number: 10026156)

Owner / Operator Contact Address

No 29 Junxian Road, Northwest Furniture Industrial Park, Lantian, Xi'an, CN-SN 710523, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPLINT, TRACTION COVER, CAST Bone Drill Sagittal saw Battery power supply surgical equipment for osseous tissue Reciprocating saw Orthopedic Casting Tape BANDAGE,CAST surgical power tools cast padding

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2008-06-16
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2008-06-16
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-04-01
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2025-03-27
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2013-11-08
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-03-27
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2025-03-27

Official Correspondent

Qi Yanyan

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Shaanxi Ansen Medical Technology Development 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
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

Similar Registrations

Registration Number	Establishment Name	Location
1528440	FARETEC, INC.	Painesville, OH, US
3016704566	DONGGUAN LUDA INDUSTRIAL CO., LTD	Dongguan Guangdong, CN
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN
1000560772	BIOSCULPTOR CORPORATION	Hialeah, FL, US
8010099	MEDICON, E.G.	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007084590. Last updated year: 2026. Please use registration number 3007084590 when referencing this establishment in official correspondence.